Trials@uspto.gov Paper 69 Tel: 571-272-7822 Entered May 4, 2017

UNITED STATES PATENT AND TRADEMARK OFFICE

_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

_______________

VARIAN MEDICAL SYSTEMS, INC., Petitioner,

v.

WILLIAM BEAUMONT HOSPITAL, Patent Owner.

____________

Case IPR2016-00170 Patent 7,471,765 B2

____________

Before MICHAEL W. KIM, KALYAN K. DESHPANDE, and MATTHEW R. CLEMENTS, Administrative Patent Judges.

DESHPANDE, Administrative Patent Judge.

FINAL WRITTEN DECISION Inter Partes Review

35 U.S.C. § 318(a); 37 C.F.R. § 42.73

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I. INTRODUCTION

A. Background

Varian Medical Systems, Inc. (“Petitioner”) filed a Petition to institute

an inter partes review of claims 1‒13 and 20‒31 of U.S. Patent No.

7,471,765 B2 (Ex. 1101, “the ’765 patent”). Paper 1 (“Pet.”). William

Beaumont Hospital (“Patent Owner”) filed a Preliminary Response. Paper

11 (“Prelim. Resp.”).

Pursuant to 35 U.S.C. § 314, we instituted inter partes review of the

ʼ765 patent, on May 5, 2016, under 35 U.S.C. § 103(a), as to claims 1‒13

and 20‒31 on the basis that these claims would have been obvious over

Cho,1 Antonuk,2 Jaffray 1997,3 Adler,4 and Depp.5 Paper 14 (“Dec.”).

Patent Owner filed a Response (Paper 26, “PO Resp.”), and Petitioner

filed a Reply (Paper 42, “Pet. Reply”). A consolidated oral hearing was held

on January 31, 2017, and the hearing transcript has been entered in the

record. Paper 66 (“Tr.”). Patent Owner also filed a Motion to Exclude

1 P.S. Cho et al., Cone-beam CT for radiotherapy applications, Phys. Med. Biol., 40:1863-83 (1995) (Ex. 1105, “Cho”). 2 L.E. Antonuk et al., Thin-Film, Flat-Panel, Composite Imagers for Projection and Tomographic Imaging, IEEE Transactions on Medical Imaging, 13:482-90 (1994) (Ex. 1106, “Antonuk”). 3 D.A. Jaffray et al., Exploring “Target Of The Day” Strategies for A Medical Linear Accelerator With Conebeam-CT Scanning Capability, Proceedings of the 12th International Conference on the Use of Computers in Radiation Therapy, Medical Physics Publishing, pp. 172-75 (1997) (Ex. 1107, “Jaffray 1997”). 4 U.S. Patent No. 5,207,223, issued May 4, 1993 (Ex. 1103). 5 U.S. Patent No. 5,427,097, issued June 27, 1995 (Ex. 1104).

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(Paper 49, “PO Mot.”), to which Petitioner filed an Opposition (Paper 55,

“Pet. Opp.”) and Patent Owner filed a Reply (Paper 59, “PO Reply”).

After the oral hearing, we authorized additional briefing on the proper

claim construction of the phrase “wherein said computer receives said image

of said object and based on said image sends a signal to said radiation source

that controls said path of said radiation source,” as recited by independent

claim 1 of U.S. Patent 6,842,502 B2, and as similarly recited by independent

claims 1, 7, 20, and 26. Paper 65. Patent Owner filed a Response (Paper 67)

and Petitioner filed a Response (Paper 68).

We have jurisdiction under 35 U.S.C. § 6. This Final Written

Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.

Pursuant to our jurisdiction under 35 U.S.C. § 6, we conclude, for the

reasons discussed below, Petitioner has not shown by a preponderance of the

evidence that claims 1–13 and 20‒31 of the ʼ765 patent are unpatentable

under 35 U.S.C. § 103(a).

B. Related Proceedings

The parties indicate that the ’765 patent is involved in the following

district court case: Elekta Ltd. and William Beaumont Hosp. v. Varian Med.

Sys., Inc., Case No. 2:15-cv-12169-AC-MKM (E.D. Mich.). Pet. 1; Paper 4,

2. Petitioner and Patent Owner identify further the following inter partes

reviews that also involve the ’765 patent: IPR2016-00169 and IPR2016-

00171. Pet. 1; Paper 4, 1. Patent Owner identifies further the following

inter partes reviews directed to U.S. Patent 6,842,502 B2 (“the ’502

patent”), which the ’765 patent claims priority to: IPR2016-00160,

IPR2016-00162, IPR2016-00163, and IPR2016-00166. Paper 4, 2. Patent

Owner identifies further the following inter partes reviews directed to U.S.

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Patent 7,826,592 B2, which claims priority to the ’765 patent: IPR2016-

00187. Id.

C. The ʼ765 Patent

The ’765 patent discloses that it is directed to a cone-beam computed

tomography system that employs an amorphous silicon flat-panel imager for

use in radiotherapy applications where images of a patient are acquired with

the patient in a treatment position on a treatment table. Ex. 1101, 1:16–21.

Figure 17(b) (below) depicts a diagrammatic view of one orientation of an

exemplary wall-mounted cone beam computerized tomography system

employing a flat-panel imager. Id. at 6:48–52.

Specifically, Figure 17(b) above shows wall-mounted cone beam

computerized tomography system 400 including an x-ray source, such as x-

ray tube 402, and flat-panel imager 404 mounted on gantry 406. Id. at

19:41‒43. X-ray tube 402 generates beam of x-rays 407 in a form of a cone

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or pyramid. Id. at 19:43‒46. Flat-panel imager 404 employs amorphous

silicon detectors. Id. at 19:46‒47.

D. Illustrative Claim

Petitioner challenges claims 1‒13 and 20‒31 of the ’765 patent. Pet.

14‒59. Claim 1 is illustrative of the claims at issue and is reproduced below:

1. A radiation therapy system comprising: a radiation source that moves about an object and directs a

beam of radiation towards said object; a cone-beam computed tomography system comprising:

an x-ray source that moves about said object and emits toward said object from multiple positions around said object x-ray beams in a cone-beam form;

a flat-panel imager positioned to receive x-rays after at least a portion of said x-ray beams pass through said object, said imager providing an image that contains three-dimensional information concerning said object based on a plurality of two-dimensional projection images; and

a computer coupled to said cone-beam computed tomography system, wherein said computer receives said three-dimensional information and based on said three dimensional information received controls a path of said beam of radiation through said object by controlling a relative position between said radiation source and said object, wherein said receiving said x-rays by said flat panel imager is performed substantially at a time of occurrence of said controlling said path of said beam of radiation through said object.

Ex. 1001, 28:2–24.

E. Instituted Ground of Unpatentability

We instituted inter partes review of claims 1–13 and 20‒31 of the

’765 patent under 35 U.S.C. § 103(a) as obvious over a combination of Cho,

Antonuk, Jaffray 1997, Adler, and Depp. Dec. 23.

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II. ANALYSIS

A. Claim Construction

We interpret claims of an unexpired patent using the broadest

reasonable interpretation in light of the specification of the patent in which

they appear. See 37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs., LLC

v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest

reasonable interpretation standard as the claim construction standard to be

applied in an inter partes review proceeding). Under the broadest

reasonable interpretation standard, claim terms are generally given their

ordinary and customary meaning, as would be understood by one of ordinary

skill in the art, in the context of the entire disclosure. In re Translogic Tech.

Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). See Vivid Techs., Inc. v. Am.

Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms

need be construed that are in controversy, and only to the extent necessary to

resolve the controversy.”).

In our Decision on Institution, we were not persuaded that the terms

“computer” (claim 1), “controller” (claim 7), “structure” (claim 20), and

“support table” (claim 26) fail to recite sufficiently definite structure, and,

therefore, we declined to construe these terms as means-plus-function

limitations in accordance with 35 U.S.C. § 112 ¶ 6. Dec. 10‒12. Neither

Patent Owner nor Petitioner provide any more argument or evidence to

disturb our interpretation of these terms. See PO Resp. 12. Accordingly, we

do not construe these terms as means-plus-function limitations under 35

U.S.C. § 112 ¶ 6. See SAS Institute, Inc. v. ComplementSoft, LLC., 825 F.3d

1341, 1351 (Fed. Cir. 2016) (The Board may not change a claim

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interpretation from the institution decision where neither party anticipated

that “already-interpreted terms were actually moving targets.”).

Patent Owner offers constructions for the terms “radiation therapy

system,” “cone-beam tomography system,” and “an image that contains

three-dimensional information concerning said object based on a plurality of

two-dimensional projection images.” PO Resp. 12‒17. In addition, after

oral argument, we authorized briefing on the construction of “wherein said

computer receives said image of said object and based on said image sends a

signal to said radiation source that controls said path of said radiation

source,” as recited by independent claim 1 of the ’502 patent, and as

similarly recited by independent claims 1, 7, 20, and 26. Paper 65. Both

parties submitted briefing. Papers 67, 68.

For purposes of this Decision, we determine that it is necessary to

construe only (1) “substantially at a time;” (2) the claim phrase containing

“three-dimensional information;” and (3) “wherein said computer receives

said three-dimensional information and based on said three dimensional

information received controls a path of said beam of radiation through said

object by controlling a relative position between said radiation source and

said object.”

1. “substantially at a time”

In our Decision on Institution, we construed “substantially at a time”

to mean “substantially at the same time,” where the “receiving” of the x-rays

is substantially at the same time of the “controlling” of the radiation path.

Dec. 7‒9. Neither Patent Owner nor Petitioner provides any more argument

or evidence to disturb our construction of this term. See PO Resp. 12.

Accordingly, after considering our initial construction anew in light of

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Patent Owner’s assertions, we construe “substantially at a time” to mean

“substantially at the same time,” where the “receiving” of the x-rays is

substantially at the same time of the “controlling” of the radiation path.

2. “an image that contains three-dimensional information concerning said object based on a plurality of two-dimensional projection images”

Independent claim 1 recites “an image that contains three-dimensional

information concerning said object based on a plurality of two-dimensional

projection images.” Independent claims 7, 20, and 26 recite substantially

similar limitations. Petitioner asserts that “three-dimensional information”

should be construed as “information concerning three dimensions of an

object (such as length, width, and depth).” Pet. 17 (citing Ex. 1101, 3:41–

44; Ex. 1102 ¶ 39); Pet. Reply 1–4 (citing Exs. 1500 ¶¶ 9–23;6 1502, 78:22–

80:16, 83:14–87:11, 135:10–136:11).7 Patent Owner asserts that the

aforementioned claim limitation, in its entirety, should be construed as “a

volumetric image of an object generated by reconstructing 2-D projection

images.” PO Resp. 14–17 (citing Ex. 1101, 1:40–50, 2:44–56, 3:41‒56,

5:5–9, 16:24‒28, 16:39‒42; Ex. 2080 ¶¶ 84–89). We agree with Petitioner.

We begin first with the claim language, and note that “three-

dimensional information” appears facially to be co-extensive with any

information relevant to three-dimensions. We discern that “length, width,

6 In evaluating the assertions set forth in the Declaration of James Balter Ph.D. in Support of Petitioner’ Reply (Ex. 1500), we considered Patent Owner’s Motion for Observations on the Cross-Examination of Dr. James Balter (Paper 48) and Petitioner’s Response to Patent Owner’s Motion for Observations on Cross-Examination (Paper 56). 7 In the Decision on Institution, we preliminarily agreed with Petitioner’s proposed construction of “three-dimensional information.” Dec. 9–10.

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and depth” are just such information. We have considered Patent Owner’s

above-cited portions of the ’765 patent, but are unpersuaded that those

portions narrow “three-dimensional information” with sufficient “reasonable

clarity, deliberateness, and precision” such that one of ordinary skill would

have understood “three-dimensional information” as co-extensive with

Patent Owner’s proffered construction. In re Paulsen, 30 F.3d 1475, 1480

(Fed. Cir. 1994). For example, column 2, lines 44‒56 certainly disclose that

“volume” is desirable, but does not provide any equivalence between “three-

dimensional information” and “volume.” Indeed, column 2, lines 55–56

disclose “provide information regarding the location of soft-tissue target

volumes,” indicating that “information” is a subset of “volume.” In another

example, column 3, lines 41–56, mentions “three-dimensional (3-D)

images,” which we agree would appear to require “volumetric data;”

however, the claim limitation at issue is the broader term “three-dimensional

information.” In a further example, column 9, line 54‒64, clearly refers to

“volumetric data,” but does not indicate its relation to “three-dimensional

information.” In yet another example, column 16, lines 23–25 and 38–42,

do not recite “three-dimensional information,” instead disclosing “3-D

structure” and “3-D nature” in relation generally to “volumetric data,” but,

again, not in a manner sufficient to indicate a particular relationship.

Finally, in regards to assertions set forth in the Declaration of

Dr. Hashemi, we discern some merit in his assertion that when reading the

claim limitation “three-dimensional information” in conjunction with

another claim limitation “cone-beam computed tomography,” “a CBCT

image is a volumetric image that provides the location, shape, and spatial

orientation of the target volume in all directions, not just its length, width,

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and depth.” Ex. 2080 ¶ 85. Furthermore, the claim limitation does not

preclude an image having more information than “three-dimensional

information concerning said object” (such as length, width, and depth),

“based on a plurality of two-dimensional projection images.” Under Patent

Owner’s construction, however, the image would be required to have such

information. We are unpersuaded that such information is required under a

proper construction of “three-dimensional information” for the reasons set

forth supra.

We construe “three-dimensional information” as “information

concerning three dimensions of an object (such as length, width, and

depth).”

3. “wherein said computer receives said three-dimensional information and based on said three dimensional information received controls a path of said beam of radiation through said object”

Independent claim 1 recites “wherein said computer receives said

three-dimensional information and based on said three-dimensional

information received controls a path of said beam of radiation through said

object.” Independent claims 7, 20 and 26 recite substantially similar

limitations.8

8 Patent Owner asserts that the limitation “wherein said computer receives said three-dimensional information and based on said three dimensional information received controls a path of said beam of radiation through said object” (hereinafter “controls a path”) is unique to independent claim 1, and “is not found in any other claims in this proceeding.” Paper 67, 1 n.1. We do not agree with Patent Owner. As an initial matter, dependent claims 2‒6 incorporate this limitation by dependence on independent claim 1. Furthermore, independent claim 7 recites “a controller to control a path of said radiation through said object,” independent claim 20 recites “said radiation therapy system has a structure for controlling a path of said beam

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Petitioner asserts that “[a person of ordinary skill in the art] would

understand this claim language to encompass both a computer system

operated by a user and a system that autonomously carries out the recited

control function.” Paper 68, 1. Patent Owner agrees that “based on the

intrinsic evidence and basic principles of claim construction, the relevant

limitation of claim 1 of the ’765 patent should be construed to encompass a

computer configured to permit human operation to perform the recited

control function.” Paper 67, 5.

Both parties agree that this construction is supported by both the

intrinsic evidence and the extrinsic evidence. Paper 68, 1–5 (citing

Ex. 1101, Abstract, 4:56–61, claims 1, 7, 13, 20, 26, 31);9 Paper 67, 1–5

(citing Ex. 1001, 26:12–27, claim 1; Ex. 1112, 125‒126; Paper 66, 44:22‒

45:13; Ex. 2084, WBH_Elekta_02082, WBH_Elekta_02116,

WBH_Elekta_02169).

We agree. We, therefore, construe “wherein said computer receives

said image of said object and based on said image sends a signal to said

of radiation through said object,” and independent claim 26 recites “said support table controls a path of said beam of radiation through said object.” As neither party has explained, and we are unable to discern independently, any substantive differences between the aforementioned limitations, we determine that all of these limitations are substantially similar to the “controls a path” limitation of independent claim 1. Dependent claims 8‒13, 21‒25, and 27‒31 incorporate these limitations from independent claims 7, 20, and 26 respectively. Accordingly, we determine that all of the remaining challenged claims, claims 2‒13 and 20‒31, recite substantially similar limitations to the “controls a path” limitation of independent claim 1. 9 Petitioner further cites to papers and exhibits filed in IPR2016-00169. Paper 68 (citing IPR2016-00169: Ex. 1500 ¶¶ 36–38; Ex. 1502, 120:14–121:11; Ex. 2080 ¶¶ 61‒65, 108, 109, 126‒130).

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radiation source that controls said path of said radiation source” to

encompass a person or user operating the computer to perform the recited

control functions. As discussed above, independent claims 7, 20, and 26

recite similar limitations, and, therefore, we interpret these limitations to

similarly encompass a person or user operating the computer to perform the

recited control functions.

B. Level of Ordinary Skill in the Art

“Section 103(a) forbids issuance of a patent when ‘the differences

between the subject matter sought to be patented and the prior art are such

that the subject matter as a whole would have been obvious at the time the

invention was made to a person having ordinary skill in the art to which said

subject matter pertains.’” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406

(2007).

Dr. Balter, Petitioner’s expert, proffers that a hypothetical person of

ordinary skill in the art, with respect to and at the time of the’765 Patent,

would have the following qualifications: “a medical physicist with a Ph.D.

(or similar advanced degree) in physics, medical physics, or a related field,

and two or more years of experience in radiation oncology physics and

image processing/computer programming related to radiation oncology

applications.” Ex. 1102 ¶ 13. Dr. Hashemi, Patent Owner’s expert,

essentially agrees, with the only major differences to the above being that an

M.S. is acceptable in lieu of a Ph.D., and that three years of experience is

preferred. Ex. 2080 ¶ 17. Nominally, we accept Petitioner’s proffered level

of ordinary skill in the art based on Dr. Balter more complete explanation.

We note, however, that neither party has explained substantively any

significance that the difference in the proffered levels of ordinary skill in the

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art would have in the obviousness analysis. See Graham v. John Deere Co.,

383 U.S. 1, 17–18 (1966); Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.

Cir. 2001) (“[T]he level of skill in the art is a prism or lens through which a

judge, jury, or the Board views the prior art and the claimed invention.”);

Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991) (“The

importance of resolving the level of ordinary skill in the art lies in the

necessity of maintaining objectivity in the obviousness inquiry.”). To that

end, we note that the prior art itself often reflects an appropriate skill level.

See Okajima, 261 F.3d at 1355.

C. The Parties’ Post-Institution Arguments In our Decision on Institution, we concluded that the arguments and

evidence advanced by Petitioner demonstrated a reasonable likelihood that

claims 1–13 and 20–31 were unpatentable as obvious based on Cho,

Antonuk, Jaffray 1997, Adler, and Depp. Dec. 23. We must now determine

whether Petitioner has established by a preponderance of the evidence that

the specified claims are unpatentable over the cited prior art. 35 U.S.C.

§ 316(e). We previously instructed Patent Owner that “any arguments for

patentability not raised in the [Patent Owner Response] will be deemed

waived.” Paper 15, 3; see also 37 C.F.R. § 42.23(a) (“Any material fact not

specifically denied may be considered admitted.”). Additionally, the

Board’s Trial Practice Guide states that the Patent Owner Response “should

identify all the involved claims that are believed to be patentable and state

the basis for that belief.” Office Patent Trial Practice Guide, 77 Fed. Reg.

48,756, 48,766 (Aug. 14, 2012).

In connection with the arguments and evidence advanced by

Petitioner to support its positions that Patent Owner chose not to address in

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its Patent Owner Response, the record now contains persuasive, unrebutted

arguments and evidence presented by Petitioner regarding the manner in

which the asserted prior art teaches corresponding elements of the claims

against which that prior art is asserted. Based on the preponderance of the

evidence before us, we conclude that the prior art identified by Petitioner

describes all other limitations of the reviewed claims, except for those that

Patent Owner contested in the Patent Owner Response, which we address

below.

D. Claims 1‒13 and 20‒31 as Unpatentable over Cho, Antonuk, Jaffray 1997, Adler, and Depp

Petitioner asserts that a combination of Cho, Antonuk, Jaffray 1997,

Adler, and Depp renders obvious claims 1–13 and 20‒31. Pet. 31–59.

Patent Owner disagrees. PO Resp. 17–62. Petitioner replies. Pet. Reply 5–

24. Claims 1, 7, 20, and 26 are the independent claims for this ground.

1. Cho (Ex. 1105) Cho describes a cone-beam CT system for radiotherapy applications,

and algorithm used therein to permit an increased reconstruction volume to

be imaged using a detector of a given size. Ex. 1105, Abstract. The system

described in Cho is a digital spot imager (id. at 6), but Cho also describes the

use of a flat panel detector for real-time diagnostic X-ray imaging.

Ex. 1105, 24 (citing Antonuk). Cho describes generating a 3-D image “by

rotating the gantry over 360º at approximately 1º increments.” Ex. 1105, 9,

15–17.

2. Antonuk (Ex. 1106) Antonuk describes “Thin-Film, Flat-Panel, Composite Imagers for

Projection and Tomographic Imaging.” Ex. 1106, Title. Specifically,

Antonuk describes how “[t]he recent development of large-area, flat-panel a-

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Si:H imaging arrays is generally expected to lead to real-time diagnostic and

megavoltage x-ray projection imagers with film-cassette-like profiles.” Ex.

1106, Abstract. According to Antonuk, “[t]he construction, operation, and

properties of the arrays have been extensively reported.” Ex. 1106, 3. “It is

widely perceived that part of the solution is to obtain imaging information

with the portal beam immediately prior to and/or during the treatment.” Ex.

1106, 5. “Toward this aim of patient verification, a variety of real-time

megavoltage imaging devices, including our a-Si:H imager, have been

developed over the last decade.” Ex. 1106, 5. “This composite imager

would be positioned behind the patient in the middle of the megavoltage

radiation field during imaging.” Ex. 1106, 6, Fig. 5. In an alternative

configuration, “[s]everal a-Si:H x-ray detectors rotate with an x-ray tube

collecting conebeam projection data inside the bore of a PET machine.”

Ex. 1106, 8.

3. Jaffray 1997 (Ex. 1107) Jaffray 1997 describes “a conebeam-computed tomography (CB-CT)

scanner for installation on our medical linear accelerator.” Ex. 1107, 4.10 A

schematic of the dual-beam imaging system is shown in Figure 1 of Jaffray

1997, which is reproduced below.

10 Many Exhibits, such as Exhibit 1107, include two page numbers: the original page number from the source material itself, and the page numbers added by the parties. For consistency, we use the page numbers added by the parties.

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Ex. 1107, 5. As shown in Figure 1, “[t]wo fluoroscopic imaging systems are

attached to a Philips SL-20 medical linear accelerator; one detects the

megavoltage image, the other a kV image produced with a kV beam

projected at 90º to the treatment beam axis.” Ex. 1107, 4. Jaffray 1997

states that the “gantry is rotated continuously” in order to generate a

“conebeam imaging sequence consist[ing] of ~100 exposures over 194º of

rotation.” Ex. 1107, 5.

4. Adler (Ex. 1103) Adler teaches an apparatus and method for extending a surgical

instrumentality to a target region in a patient, for example, for performing

stereotaxic surgery using an x-ray linear accelerator. Ex. 1103, 1:6–10.

Specifically, Adler teaches that a 3-dimensional mapping of a mapping

region of at least a portion of a living organism is prepared. Ex. 1103, 3:64–

68. First and second diagnostic beams are then passed through the mapping

region, and are used to produce respective first and second images of

respective first and second projections within the mapping region. Ex. 1103,

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4:5–10. Adler then teaches that the 3-dimensional mapping and the first and

second images are compared to derive therefrom data representative of a

real-time location of a target portion of the mapping region. Ex. 1103, 4:41–

46. Adler teaches further “adjusting the relative position of the beaming

apparatus 20 and the patient 14 as needed in response to data which is

representative of the real time location of the target region 18.” Ex. 1103,

7:37–40.

5. Depp (Ex. 1104) Depp teaches an apparatus for and method of carrying out stereotaxic

radiosurgery and/or radiotherapy on a particular target region within a

patient utilizing previously obtained reference data indicating the position of

the target region with respect to its surrounding area, which also contains

certain nearby reference points. Ex. 1104, 1:6–12. Depp further teaches the

following:

The apparatus also utilizes a pair of diagnostic beams of radiation or target locating beams, as they will be referred to in this discussion. These beams are passed through the surrounding area containing the target region and reference points and, after passing through the surrounding area, contain data indicating the positions of the reference points within the surrounding area. This position data is collected by cooperating detectors, as described previously, and delivered to the multiprocessor computer where the latter compares it with previously obtained reference data for determining the position of the target region with respect to each of the reference points during each such comparison. The radiosurgical beam is accurately directed into the target region in substantially real time based on this information.

Ex. 1104, 11:46–61.

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6. Petitioner’s Initial Positions Petitioner asserts that a combination of Cho, Antonuk, Jaffray 1997,

Adler, and Depp renders obvious claims 1–13 and 20‒31. Pet. 31–59. For

example, claim 1 recites “[a] radiation therapy system.” Petitioner argues

that Adler and Depp disclose a system for radiotherapy that is configured for

selectively irradiating a target within a patient. Id. at 31‒32 (citing Ex.

1103, Abstract, 3:62‒68; Ex. 1104, Abstract, 1:6‒12, 1:18‒26; Ex. 1102

¶¶ 64‒65). Petitioner further argues that Antonuk and Jaffray 1997 also

disclose radiotherapy systems using a medical linear accelerator device. Id.

at 32.

Claim 1 further recites “a radiation source that moves about an object

and directs a beam of radiation towards said object.” Petitioner argues that

Adler/Depp discloses that the beaming apparatus can be adjusted such that

the collimated beam is continuously focused on the target region. Id. at 32‒

33 (citing Ex. 1103, 7:52‒58; Ex. 1104, 5:25‒31). Petitioner further argues

that Jaffray 1997 and Antonuk disclose the use of a radiation source. Id. at

33 (citing Ex. 1107, 4; Ex. 1106, 3, 5).

Claim 1 also recites “a cone-beam computed tomography system

comprising: an x-ray source that moves about said object and emits toward

said object from multiple positions around said object x-ray beams in a

cone-beam form.” Petitioner argues that Cho discloses a cone-beam

computed tomography (“CBCT”) system that generates a 3-D image by

rotating an x-ray source around an object. Id. at 33‒34 (citing Ex. 1105, 15).

Petitioner further argues that Jaffray 1997 discloses a cone beam CT

apparatus that uses a linear accelerator that obtains 3-D information from a

plurality of 2-D projection images by rotating the gantry around a patient.

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Id. at 34 (citing Ex. 1107, 4‒5). Petitioner further argues, applying the

testimony of Dr. Balter, that Antonuk discloses an x-ray source that emits

beams in a con-beam geometry. Pet. 34‒35 (citing Ex. 1106, Fig. 5; Ex.

1102 ¶ 72).

Claim 1 additionally recites “a flat-panel imager positioned to receive

x-rays after at least a portion of said x-ray beams pass through said object,

said imager providing an image that contains three-dimensional information

concerning said object based on a plurality of two-dimensional projection

images.” Petitioner argues that Cho discloses an amorphous silicon flat

panel imager (“FPI”) that detects cone-beam x-ray projection images, and

Cho specifically references to Antonuk for its FPI. Id. at 35 (citing Ex.

1105, 24). Petitioner then argues that Antonuk discloses flat panel imagers

as diagnostic x-ray detectors mounted on a linear accelerator for imaging

during radiotherapy. Id. (citing Ex. 1106, 3). Petitioner argues, as explained

by Dr. Balter, the FPI devices detect multiple x-ray beams that pass through

an object being imaged, and each FPI receives a plurality of 2-D x-rays. Id.

at 35‒36 (citing Ex. 1106, Fig. 5; Ex. 1102 ¶¶ 58, 73‒74). Petitioner argues

that Adler/Depp disclose obtaining two x-ray images at a known angle

relative to one another, and, therefore, providing three-dimensional

information about the imaged object. Id. at 36‒37 (citing 1103, 7:6‒12,

7:17‒23; Ex. 1102 ¶ 75).

Claim 1 further recites:

a computer coupled to said cone-beam computed tomography system, wherein said computer receives said three-dimensional information and based on said three dimensional information received controls a path of said beam of radiation through said object by controlling a relative position between said radiation source and said object, wherein said receiving said x-rays by said

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flat panel imager is performed substantially at a time of occurrence of said controlling said path of said beam of radiation through said object.

Petitioner argues that Adler discloses a computer, coupled to the x-ray

system, that receives three-dimensional information, as discussed above, and

adjusts the position of the radiation beam in response to the real-time three-

dimensional location information of the target. Pet. 37‒38 (citing Ex. 1103,

7:37‒40). Petitioner argues that the radiation source is adjusted in the gantry

or by moving the patient table. Id. at 38 (citing Ex. 1103, 7:42‒58).

Petitioner further argues that Depp discloses the use of diagnostic beams that

pass through target region and surrounding area, and then contain data

indicating the position of the target. Id. at 39 (citing Ex. 1104, 11:46‒61).

The substantially real time position data is used to direct the radio surgical

beam to the target region. Id. (citing Ex. 1104, 11:46‒61).

For a rationale to modify Cho, Antonuk, Jaffray 1997, Adler, and

Depp in view of each other, Petitioner sets forth such a rationale on pages

46–50 of the Petition. Petitioner performs a similar analysis for dependent

claims 2–6, 8–13, 21‒25, and 27–31. Id. at 50–59.

7. Patent Owner’s Assertions Concerning the References i. Missing Limitation

Patent Owner asserts that the Petition does not account sufficiently for

“the element of controlling the relative position of the radiation source and

tumor based on the three-dimensional information contained in the claimed

image,” because Petitioner solely relies on Adler/Depp for the

aforementioned claim element, and Adler/Depp does not disclose an image

containing three-dimensional information. PO Resp. 23–25, 29–30. As an

initial matter, we note that Patent Owner’s assertions are unpersuasive

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because they appear to presume a construction of “three-dimensional

information” as requiring volumetric information. As set forth above, we

construe “three-dimensional information” as “information concerning three

dimensions of an object (such as length, width, and depth).” Adler discloses

conducting radiosurgery using a 3-dimensional mapping (Ex. 1103, 4:41–

46) and Depp discloses conducting radiosurgery and radiotherapy on a target

region and reference points in 3-dimensional space (Ex. 1104, 11:46–61),

each of which we find corresponds properly to the aforementioned claim

limitation.

Moreover, Patent Owner’s assertions are misplaced, because

Petitioner does not rely solely on Adler/Depp for “the element of controlling

the relative position of the radiation source and tumor based on the three-

dimensional information contained in the claimed image.” PO Response

29–30; see Pet. 31–41; Pet. Reply 5. More specifically, the aforementioned

claim “element” is not recited in a single limitation of independent claim 1,

but instead appears to be an amalgamation of several express limitations,

namely, “said imager providing an image that contains three-dimensional

information concerning said object based on a plurality of two-dimensional

projection images” and “a computer coupled to said cone-beam computed

tomography system, wherein said computer receives said three-dimensional

information and based on said three dimensional information received

controls a path of said beam of radiation through said object by controlling a

relative position between said radiation source and said object.” While for

the latter limitation, Petitioner may rely solely on Adler/Depp, for the former

limitation, Petitioner also relies on Cho/Antonuk/Jaffray 1997, the

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combination of which we are persuaded meet the entire limitation at issue.

Pet. 35‒39; Pet. Reply 5.

Patent Owner asserts also that “[n]one of these references . . . either

alone or in combination, shows the actual use of an FPI in the context of

CBCT in the treatment room. (Ex. 2080 ¶ 119).” PO Resp. 27. Patent

Owner’s assertions are misplaced, as Petitioner relies on a combination of

references for the above, e.g., Cho/Antonuk for the FPI, Cho/Jaffray ’97 for

CBCT, and Adler/Depp for the treatment room. See Pet. 31‒36. Patent

Owner’s arguments are unpersuasive because they are directed to each

individual reference’s failure to disclose the claim limitations, rather than to

the combination of prior art disclosures. See In re Merck & Co. Inc., 800

F.2d 1091, 1097 (Fed. Cir. 1986). Insofar as Patent Owner requires more by

using the word “actual,” we note that obviousness is a hypothetical exercise,

given certain factual underpinnings, and so an example of “actual use” is

unnecessary and beside the point.

ii. Teaching Away

Petitioner sets forth their rationale, for their proffered modification of

the radiation therapy systems of Adler/Depp to include the CBCT/FPI

system of Cho/Antonuk/Jaffray 1997, on pages 46–50 of the Petition which,

for the reasons set forth below, we agree with and adopt. Patent Owner

asserts that one of ordinary skill would not have modified the radiation

therapy systems of Adler/Depp to include the CBCT/FPI system of

Cho/Antonuk/Jaffray 1997, because both timing and dosage considerations

teach away from the proposed combination. PO Resp. 31–39. We disagree.

We begin with timing considerations. PO Resp. 31–36.

Fundamentally, Patent Owner asserts that replacing the orthogonal 2-D

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images projections of Adler/Depp with the CBCT-acquired images of

Cho/Antonuk/Jaffray 1997 would represent “very poor methodology”

because the CBCT system takes a significantly longer period of time to

acquire and process images from a patient than the 2-D image system, e.g.,

60 seconds to acquire the image, and 30–50 minutes to reconstruct the entire

CT conebeam data set. Id. at 33‒35. According to Patent Owner, such a

delay is detrimental in the context of sending targeted radiation to a specific

volume within the patient, because during that time, the patient from whom

the images was acquired would most likely have shifted positions. Id.

We are unpersuaded for several reasons. Primarily, we are

unpersuaded because a fundamental assumption made by Patent Owner is

that the patient must remain unrestrained. Patent Owner makes this

assumption based on the assertion that “the primary goal of the Adler/Depp

systems is to permit a patient to be relatively unrestrained during the

radiotherapy procedure.” PO Resp. 33. We have reviewed Patent Owner’s

supporting evidence, and are unpersuaded that the evidence supports Patent

Owner’s assertion that “the primary goal of the Adler/Depp systems is to

permit a patient to be relatively unrestrained during the radiotherapy

procedure.” For example, Patent Owner cites to certain paragraphs of

Dr. Hashemi’s Declaration, which in turn cite to certain portions of Depp.

Ex. 2080 ¶¶ 117, 133, 136 (citing Ex. 1104, 11:66–12:23, Fig. 9). We have

reviewed those portions of Depp, and find that while they do disclose that

target location and treatment periods are on the order of seconds, they do not

mention anything about “the primary goal of the Adler/Depp systems is to

permit a patient to be relatively unrestrained during the radiotherapy

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procedure.”11 Accordingly, absent such an evidentiary foundation, we do

not find credible Dr. Hashemi’s assertions concerning this matter.

Even without explicit analysis by Patent Owner, we logically

understand the connection between longer image acquisition and processing

times, and the higher likelihood of interim patient movement. Absent the

aforementioned “primary goal,” however, we are unclear as to why the

converse of that goal would not be correct, i.e., that one of ordinary skill

would have resolved the timing consideration by restraining the patient.

Indeed, in opposition, Petitioner asserts, and we agree, that “POSA would

understand that in the majority of radiotherapy treatment settings, patients

are in fact restrained to some degree.” Pet. Reply 7‒8 (citing Ex. 1500

¶¶ 33–35; Ex. 2080 ¶¶ 54–55; Ex. 1502, 142:23–143:19). In particular, we

are persuaded by the consistency of Dr. Balter’s and Dr. Hashemi’s

testimony that molds were used in 2000 to minimize unwanted patient

motion during treatment. Ex. 1500 ¶ 35; Ex. 2080 ¶ 55.

Patent Owner also cites to the cross-examination testimony of

Dr. Balter in support of its assertions concerning timing consideration.

PO Resp. 33‒34 (citing Ex. 2011, 95:14‒96:8, 98:9–98:19). We have

reviewed that testimony, however, and have determined it is inapposite

because there, Dr. Balter was opining on the appropriateness of certain

methodologies concerning how to detect “gross patient body motion,” and

not acquiring images for rendering treatment. Furthermore, Dr. Balter

11 We also note that the use of the word “primary” indicates a general preference, which “does not criticize, discredit, or otherwise discourage the solution claimed . . . ,” as generally required for a showing of a teaching away. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).

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testified CBCT may be an acceptable methodology for other forms of

motion, such as “prostate motion,” depending on the timing. See Pet. Reply

8 (“Dr. Balter made this point clear when he explained that there are many

facets of ‘intratreatment’ imaging, of which ‘gross patient body motion’ is

but one . . . .”) So, here, we have another way in which any longer timing

from CBCT image acquisition and processing can be dealt with, namely, by

restricting the volume from which an image is acquired.

Patent Owner admits that “Jaffray 1997 suggests that this

reconstruction time can be reduced by various methods.” PO Resp. 35.

Petitioner asserts the same. Pet. Reply 8–9 (citing Ex. 1107, 5–6). Patent

Owner goes on to fault Petitioner for not providing sufficient analysis as to

how such reconstruction could be accomplished to meet the primary goals of

Adler/Depp. PO Resp. 35–36 (citing Ex. 2080 ¶¶ 133–138). As noted

above, however, we are unpersuaded that Patent Owner’s assertions

concerning the primary goals of Adler/Depp are credible, and, thus, a

finding that the reconstruction times could be reduced actually weighs

against Patent Owner’s assertions.

Finally, Petitioner asserts that “[Patent Owner] has failed to account

for the trade-offs associated with the combination of a 3D CBCT system

with the apparatus and methods disclosed in Adler/Depp.” Pet. Reply 8‒9

(citing Pet. 49; Dec. 19–21). As an initial matter, we note that it is

Petitioner’s, and not Patent Owner’s burden, to account for the tradeoffs.

Moreover, we note that the cited portions of the Petition and Decision on

Institution referenced possible benefits to the proffered combination, and

made no mention of tradeoffs. Finally, Petitioner does not cite to any

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evidence to support this assertion. Accordingly, it is accorded little weight

in our above analysis.

We move on to dosage considerations. PO Resp. 31–32, 36–38

(citing Ex. 2011, 99:19–101:22; Ex. 2080 ¶¶ 133, 139–142). Specifically,

Patent Owner asserts that replacing the orthogonal 2-D images projections of

Adler/Depp with the CBCT acquired images of Cho/Antonuk/Jaffray 1997

would significantly increase the amount of radiation to which a patient is

exposed, increasing significantly and commensurately the risk of cancer

from that radiation. Id. According to Patent Owner, one CBCT image

already requires 300 exposures while one 2-D x-ray snapshot only requires

two, and that an unrestrained patient would require multiple image

acquisitions due to movement. Id. at 37 (citing Ex. 2080 ¶ 140). We are

unpersuaded by these assertions as well, primarily because Patent Owner

again assumes the patient is unrestrained. As set forth above, however, we

are unpersuaded that such an assumption is credible, in which case, for a

restrained patient, there is less of a need for multiple exposures from the

CBCT system. Petitioner asserts the same. Pet. Reply 9. Furthermore, we

find that multiple 2-D x-ray snapshots would be necessary to convey the

same amount of information as one 3-D CBCT image, indicating that the

exposure disparity between the two systems would be significantly less than

the 150:1 ratio proffered by Patent Owner.

Along those lines, Petitioner provides analysis and evidence that the

radiation dosage from one full rotation CBCT scan is well within acceptable

parameters, as measured in centigray (“cGy”). Pet. Reply 10 (citing

Ex. 1105, 22; Ex. 1107, 5; Ex. 1500 ¶¶ 38–48; Ex. 1507, 7). Specifically,

Jaffray 1997 discloses that “[d]aily imaging dose of up to 10 cGy will

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exceed the doses currently accepted for portal filming practice,” and further

discloses that “[t]he total dose required to locate the prostate – fat boundary

is estimated to be ~4 cGy for a 5mm slice thickness.” Ex. 1107, 5. Pouliot

discloses that “[i]n this study, the radiation dose delivered to the patient by

MV CBCT was 15 cGy. As will be discussed below, we hope to decrease

the dose per scan to 2 cGy.” Ex. 1507, 7. Dr. Balter calculates that the total

exposure of 1590 mR from one CBCT scan in Cho is equivalent to about 1.4

cGy (Pet. Reply 10 (citing Ex. 1105, 22; Ex. 1500 ¶ 40)), and Cho discloses

that such a dosage “compares favourably with exposures from diagnostic

CT” (Ex. 1105, 22). Accordingly, while we acknowledge that other

considerations, such as volume of scan image desired, may affect dosage, we

find, in general, that dosages at issue for one full rotation CBCT scan are on

the order of 1.4 to 4 cGy, are below the accepted limits of around 10 to 15

cGy, and “compare[ ] favourably with exposures from diagnostic CT.”

Ex. 1105, 22. We determine that this finding weighs heavily against Patent

Owner’s assertions concerning dosage.

In summary, Patent Owner asserts that Petitioner’s proffered rationale

for replacing the orthogonal 2-D image projections of Adler/Depp with the

CBCT-acquired images of Cho/Antonuk/Jaffray 1997, namely, “improved

image accuracy,” is insufficient because it is outweighed by the

aforementioned timing and dosage considerations. PO Resp. 38–39 (citing

Ex. 2011, 87:13–88:16; Ex. 2080 ¶¶ 137, 143–146). As set forth above,

however, we are unpersuaded that Patent Owner’s assertions concerning

timing and dosage considerations are credible. Instead, absent that factual

basis, we are persuaded that Petitioner’s proffered rationale is sufficient.

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iii. Reasonable Expectation of Success

Patent Owner asserts further that one of ordinary skill would not have

modified the radiation therapy systems of Adler/Depp to include the

CBCT/FPI system of Cho/Antonuk/Jaffray 1997, because one of ordinary

skill would not have had a reasonable expectation of success with respect to

the modification. PO Resp. 39–53. We disagree.

Patent Owner asserts that one of ordinary skill would not have had a

reasonable expectation of success with respect to the modification because

“[a]t the time of the ’765 patent—and even today—the quality of CBCT

images suffered greatly for two reasons.” PO Resp. 41 (citing Ex. 2080

¶¶ 150‒160). First, Patent Owner asserts that the presence of various

“artifacts” resulting from the modification would have led one of ordinary

skill to conclude that the resulting image quality to be so poor as to be

“‘inadequate for medical diagnosis.’” Ex. 2080 ¶ 151 (quoting Ex. 2020,

2:28‒34) (emphasis omitted); PO Resp. 41–43 (citing Exs. 2020, 2021,

2022, 2080 ¶¶ 150–160). Petitioner responds that (1) the challenged claims

do not require any specific level of image quality, and (2) that while certain

levels of image quality may be insufficient for some medical diagnoses, it

does not follow that the image of that quality is unsuitable for all medical

diagnoses. Pet. Reply 11–13 (citing Exs. 1500 ¶¶ 51–59, 1502). We agree

with Petitioner.

We begin with Patent Owner’s citation to Exhibit 2020, the full

excerpt of which reads as follows:

Depending on the scanning configuration employed to obtain the cone beam projection data, the data set in Radon space may be incomplete. While image reconstruction through inverse Radon transformation certainly can proceed, artifacts

Case IPR2016-00170 Patent 7,471,765 B2

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may be introduced, resulting in images which can be inadequate for medical diagnosis or part quality determination purposes.

Ex. 2020, 2:28–34 (emphasis added). We do not read Exhibit 2020 as

disclosing that all CBCT/FIP images are so poor as to be “‘inadequate for

medical diagnosis’;” only that some such images may be inadequate,

“[d]epending on the scanning configuration employed,” indicating that under

some scanning configurations, the image quality would be adequate. Id.

We next proceed to Patent Owner’s citation to Exhibit 2022, the full

excerpt of which reads as follows:

Various scanning geometries have been developed to ensure that the sufficiency criterion of Smith is complied with. In one such geometry, the scan path comprises a circular orbit in combination with a linear path, which is orthogonal to the plane of the circular orbit. Such combination scan path is of great practical interest, since it can be readily implemented by means of a conventional CT gantry configuration. Various algorithms are currently available for use in processing cone beam data acquired by scanning along a combined circle and line path, and constructing an image therefrom. However, one of such algorithms is of the shift-variant filtering back projection form, which is comparatively difficult to implement in practice. Other of such algorithms have been found to contain artifacts, and are not sufficiently exact or accurate. Still other algorithms require excessive data processing steps, resulting in inefficient image reconstruction.

Ex. 2022, 1:42–51 (emphases added). Similar to our analysis above, we do

not read Exhibit 2022 as disclosing that all algorithms have inadequate

image quality; only that various algorithms have various strengths and

weakness, one weakness of certain algorithms being “artifacts.”

Patent Owner further cites to paragraphs 150–160 of Dr. Hashemi’s

Declaration which, in addition to providing analysis, cite to additional

Exhibits 2021, 2023, 2025, 2026 for support. We have reviewed

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Dr. Hashemi’s testimony, as well as the cited portions of those Exhibits, and

determine that our analysis is the same as set forth above; that while the

presence of artifacts is certainly undesirable, their presence alone is

insufficient to support Patent Owner’s assertion that the resulting image

quality for the proffered modification would have been “‘inadequate for

medical diagnosis.’”

Finally, there is no doubt that the claims do not specify any minimum

level of image quality to be considered a success. When viewed in

conjunction with the fact that the aforementioned evidence, as a whole,

indicates that at least some of the resulting images would have sufficient

quality for certain medical diagnoses, even with artifacts, we are persuaded

that Petitioner has met its burden of showing adequately a reasonable

expectation of success with respect to image quality.

Second, Patent Owner makes similar assertions with respect to

“increased noise” and “image quality.” PO Resp. 43–45 (citing Exs. 2023–

2026, 2080 ¶¶ 155, 157‒160). Petitioner’s response and our analysis is

similar to that set forth above for “artifacts.”

For Exhibit 2023, Patent Owner’s assertion that “[t]his is one of the

‘major limiting factors for the current image quality in flat-panel based

CBCT’” (PO Resp. 43 (quoting Ex. 2023, 187)) is somewhat misplaced,

because that paragraph is discussing “scatter,” as opposed to “noise,”

although we acknowledge that Exhibit 2026 discloses that “noise” and

“scatter” are related (Ex. 2026, 708). In any case, later in that same

paragraph, Exhibit 2023 notes “[s]everal scatter correction algorithms have

been proposed in the literature to control these artifacts,” indicating that the

presence of “scatter” is not fatal to image quality. Ex. 2023, 187–188.

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Patent Owner’s later citation to the subsequent paragraph of Exhibit

2023 is more relevant, in that it explicitly is directed to “noise,” has a “loss

of diagnostic information,” and concludes with “a practical solution to

suppress noise has not yet been developed.” Ex. 2023, 188. While

seemingly phrased in the absolute, i.e., that there is no practical solution to

suppress noise, the previous sentence provides context that some algorithms

do exist to reduce noise “by a factor of 3.6” and “from 10.6% to 1.7%.”

Ex. 2023, 188. Accordingly, this paragraph also supports the conclusion that

some noise suppression techniques are known, and, in any case, does not

indicate that the “noise” results in a completely unusable image, especially

given that the claim does not require any particular image quality.

Regarding the rest of the cited portions of Exhibits 2023, 2024, 2025,

and 2026, we agree with Patent Owner that the cited portions support the

proposition that noise is certainly a disadvantage of CBCT. It does not

follow, however, that noise in itself would definitively counsel against a

reasonable expectation of success.

Patent Owner asserts additionally that “Antonuk discloses using a

CBCT-FPI system for the purpose of calculating attenuation coefficient

factors in the context of PET and SPECT scanning,” which uses radioactive

contrast agents and not x-rays, and, thus, “would not have suggested using

CBCT for patient setup in the context of radiotherapy, which does not use a

radioactive contrast agent.” PO Resp. 45–46 (citing ¶¶ 163–165). As an

initial matter, we note that this appears to be directed more to a teaching

away, as opposed to a reasonable expectation of success. In any case, the

assertion is misplaced because Petitioner relies on Adler, not Antonuk, for

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radiotherapy. Pet. 31–33. Moreover, we disagree because Antonuk

explicitly discloses radiotherapy. Ex. 1106, 5.

Patent Owner asserts further that one of ordinary skill would not have

had a reasonable expectation of success with respect to the modification

based on Antonuk, because Antonuk discloses a helical scan, which would

eliminate artifacts, but would significantly increase reconstruction time,

making it impractical for radiation therapy. PO Resp. 46 (citing Ex. 2080

¶ 165). These assertions are unpersuasive for the same reasons as set forth

above with respect to Patent Owner’s assertions concerning timing

considerations. See also Pet. Reply 13–14 (citing Exs. 1106, 1500 ¶¶ 60–63,

1502) (Fig. 5 of Antonuk discloses a patient being subjected to both

diagnostic and therapeutic x-rays).

Patent Owner makes similar assertions concerning Cho, i.e., that Cho

does not provide any evidence that the images would be of sufficient quality,

and that Cho discloses a more time-intensive reconstruction. PO Resp. 46–

47 (citing Ex. 2080 ¶¶ 166–170; Ex. 1112). These assertions are

unpersuasive for the same reasons as set forth supra. See also Pet. Reply 14

(citing Exs. 1105, 1500 ¶¶ 64–65, 1502).

Patent Owner repeats the above assertions for both Jaffray ’97 and

FPIs generally. PO Resp. 47–50 (citing Exs. 1129, 2028, 2073–2075, 2080

¶¶ 171‒183). Our analysis is similar to that set forth above, and need not be

repeated here. See also Pet. Reply 14–15 (citing Exs. 1101, 1500 ¶¶ 66–68,

1502, 1508) (“[E]ffects of image lag in flat-panel CBCT under conditions

typical of medical imaging are small, given the image lag performance of

state-of-the-art FPIs.” (Ex. 1508, 12)).

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In summary, Patent Owner asserts that one of ordinary skill would

have had no reasonable expectation of success for Petitioner’s proffered

replacement of the orthogonal 2-D image projections of Adler/Depp with the

CBCT-acquired images of Cho/Antonuk/Jaffray 1997, due to poor image

quality and timing considerations. As set forth above, however, we are

unpersuaded that image quality is relevant to the extent advocated by Patent

Owner, and that the timing considerations are not dire enough to counsel

definitively against a reasonable expectation of success. Instead, we are

persuaded that Petitioner has shown sufficiently that one of ordinary skill

would have had a reasonable expectation of success concerning Petitioner’s

proffered modification.12

8. Evidence of Secondary Considerations Patent Owner asserts that even if all of the other factors weigh in

favor of the obviousness of certain claims, those factors are outweighed by

Patent Owner’s proffered evidence concerning objective indicia of non-

obviousness, i.e., secondary considerations. PO Resp. 54–62 (citing Exs.

2011–2015, 2034, 2035, 2048, 2052, 2054, 2080, 2083). Petitioner

disagrees. Pet. Reply 15–24 (citing Exs. 1500, 1502, 1509–1515, 2011,

2015, 2033, 2035, 2048, 2056, 2071, 2072, 2080).

i. Law – Objective Indicia of Nonobviousness

Factual inquiries for an obviousness determination include secondary

considerations based on objective evidence of non-obviousness. Graham v.

12 Patent Owner addresses other references cited by Dr. Balter only in his Declaration. PO Resp. 50–53 (citing Exs. 1102, 1131, 1132, 2029–2031, 2080). As noted by Patent Owner, however, it is inappropriate for Petitioner to rely on these references to “‘fill-in’ any ‘gap’ in the Petition,” and so we have not considered those references in rendering our Decision.

Case IPR2016-00170 Patent 7,471,765 B2

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John Deere Co., 383 U.S. 1, 17–18 (1966). Notwithstanding what the

teachings of the prior art would have suggested to one of ordinary skill in the

art at the time of the invention, the totality of the evidence submitted,

including objective evidence of non-obviousness, may lead to a conclusion

that the challenged claims would not have been obvious to one of ordinary

skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).

We note that it is not sufficient that a product or its use merely be

within the scope of a claim in order for objective evidence of

nonobviousness tied to that product to be given substantial weight. There

must also be a causal relationship, termed a “nexus,” between the evidence

and the claimed invention. Merck & Co. v. Teva Pharm. USA, Inc., 395

F.3d 1364, 1376 (Fed. Cir. 2005). A nexus is required in order to establish

that the evidence relied upon traces its basis to a novel element in the claim,

not to something in the prior art. Institut Pasteur & Universite Pierre Et

Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013). Objective

evidence that results from something that is not “both claimed and novel in

the claim” lacks a nexus to the merits of the invention. In re Kao, 639 F.3d

1057, 1068 (Fed. Cir. 2011).

All types of objective evidence of nonobviousness must be shown to

have nexus. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus

generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial

success); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356,

1364 (Fed. Cir. 2012) (copying); Rambus Inc. v. Rea, 731 F.3d 1248, 1256

(Fed. Cir. 2013) (long-felt need); Muniauction, Inc. v. Thomson Corp., 532

F.3d 1318, 1328 (Fed. Cir. 2008) (praise). The stronger the showing of

nexus, the greater the weight accorded the objective evidence of

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nonobviousness. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,

776 F.2d 281, 306 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986).

“Where the allegedly obvious patent claim is a combination of prior

art elements, . . . the patent owner can show that it is the claimed

combination as a whole that serves as a nexus for the objective

evidence . . . .” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330 (Fed. Cir.

2016) (citing Rambus, 731 F.3d at 1258). “[T]here is a presumption of

nexus for objective considerations when the patentee shows that the asserted

objective evidence is tied to a specific product and that product ‘is the

invention disclosed and claimed in the patent.’” WBIP, 829 F.3d at 1329

(citations omitted). Secondary consideration evidence is accorded less

weight for claims that are considerably broader than the particular features in

the merits of the claimed invention. See ClassCo, Inc. v. Apple, Inc., 838

F.3d 1214, 1221 (Fed. Circ. 2016).

ii. Industry Praise

Patent Owner asserts that their proffered evidence of industry-wide

praise suggests that the aforementioned claims are non-obvious.

PO Resp. 54–57 (citing Exs. 2012–2015, 2052, 2054, 2080). Petitioner

disagrees. Pet. Reply 17–18 (citing Exs. 1500, 1515, 2011, 2015).

a. Linear Accelerator of Jaffray 2002

Beginning with nexus, Patent Owner cites the analysis of Dr. Hashemi

for the proposition that “the linear accelerator described in Jaffray 2002

meets each and every limitation of at least the independent Challenged

Claims.” PO Resp. 54–55 (citing Ex. 2080 ¶¶ 195–200). Petitioner does not

directly address nexus for the linear accelerator of Jaffray 2002, in that

Petitioner’s purported assertions concerning nexus actually go to the weight

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to be accorded the evidence of secondary considerations, and not nexus. See

generally Pet. Reply 16–17. Specifically, nexus is more of a preliminary

determination as to whether the claims literally cover the content set forth in

the evidence of secondary considerations. See WBIP, 829 F.3d at 1329

(“[T]here is a presumption of nexus for objective considerations when the

patentee shows that the asserted objective evidence is tied to a specific

product and that product ‘is the invention disclosed and claimed in the

patent.’”) (citations omitted). There is no factual dispute that the linear

accelerator described in Jaffray 2002 meets each and every limitation of at

least the challenged independent claims. Tr. 55:19–24 (“JUDGE KIM:

That’s what I'm trying to get at. I understand that point, but yeah, literally

infringe. Is there any exhibit where they don’t literally infringe the claim?

MR. SMITH: Your Honor, I’m not aware of -- in the little time I have left,

we’ll go through it, but I'm not aware of one as I stand up here today.”). 13,14

Any disagreement that exists, between Patent Owner and Petitioner,

goes to the weight to be accorded that evidence of secondary considerations

having a nexus. For example, Petitioner asserts “both Elekta and Varian

linear accelerator systems including CBCT-FPI can be (and often are) used

in IGRT methods that do not employ any localization based on images with

3-D information and thus have no nexus with the claims.” Pet. Reply 17

(emphasis omitted). Our reviewing court has instructed us, however, that

13 This exchange is applicable to all evidence of secondary considerations. 14 This discussion involves whether Jaffray 2002 meets each and every limitation of the challenged independent claims of both the ’502 patent and the ’765 patent with regard to the nexus requirement. See Tr. 54:6‒14, 55:1‒3 (“. . . he praised the ’502 and the ’765 technology as one of the most significant developments in the scientific literature.”).

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such an assertion should be addressed by according less weight to the

evidence of secondary considerations, and not by determining a lack of

nexus. See ClassCo, 838 F.3d at 1221 (secondary consideration evidence is

accorded less weight for claims that are considerably broader than the

particular features in the merits of the claimed invention). To that end, all of

Petitioner’s assertions concerning “nexus” have been considered when

determining the weight to be accorded the relevant evidence of secondary

considerations.

Given the above rubric, we have reviewed the relevant portions of

Dr. Hashemi’s Declaration, and find that the system described in, and

praised by, Jaffray 2002 has a nexus with independent claims 1, 7, 20, and

26. In particular, Jaffray 2002 discloses the following:

Conclusions: A kV cone-beam CT imaging system based on a large-area, flat-panel detector has been successfully adapted to a medical linear accelerator. The system is capable of producing images of soft tissue with excellent spatial resolution at acceptable imaging doses. Integration of this technology with the medical accelerator will result in an ideal platform for high-precision, image-guided radiation therapy.

Ex. 2012, WBH_Elekta_00412, Abstract. We are persuaded that this

conclusion is indisputably the focus of Jaffray 2002, and that it is

coextensive with the scope of independent claims 1, 7, 20, and 26.

Patent Owner then cites to the following sentence in a textbook

published in 2015 as both referring to, and praising, the system set forth in

Jaffray 2002: “[t]he advent of cone-beam computed tomography (CBCT) on

board another Elekta SL-20 linear accelerator was another major

breakthrough reported by Jaffray and others at William Beaumont Hospital

(Jaffray et al. 2002).” Ex. 2013, WBH_Elekta_0057; see PO Resp. 55

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(quoting Ex. 2013, WBH_Elekta_0057). Petitioner does not challenge the

weight of this citation. See generally Pet. Reply 17–18. We find that

Exhibit 2013 supports heavily Patent Owner’s assertion that there was

industry praise for the system set forth in Jaffray 2002.

Patent Owner further cites to the following sentences in an article co-

authored by Petitioner’s expert: “[p]erhaps the most significant

developments that have brought IGRT to the forefront are enhancements

recently made in application of imaging and other remote sensing devices

within treatment rooms”; “most modern treatment machines can now be

outfitted with CT devices mounted directly to the treatment gantry”

(footnote citing Jaffray 2002). PO Resp. 55–56 (citing Ex. 2015,

WBH_Elekta_00575–76). Petitioner asserts that the weight accorded these

sentences should be heavily discounted because “[t]he quotes referenced are

not tied solely to CBCT-FPI systems for IGRT, as Patent Owner argues, but

instead refer broadly to all classes of imaging modalities for IGRT,” which

includes digital radiography, cone-beam CT, and ultrasound, and “nothing in

Dr. Balter’s paper amounts to any specific praise for what is actually recited

in the claims.” Pet. Reply 17‒18. We agree that the aforementioned

citations should be discounted somewhat for the reasons asserted by

Petitioner. While we acknowledge that it is listed as only one of a plurality

of options, the article nevertheless specifically identifies cone-beam CT and

Jaffray 2002 as an advance in the field, and, thus, is still compelling

evidence of industry praise of the system of Jaffray 2002. See also

Ex. 2011, 111:3–8 (Dr. Balter crediting the early work of Jaffray 2002 as

follows: “there was certainly several efforts associated with doing this in the

community at the time. However, he certainly had a very early publication,

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and we knew his work, and it was quite appropriate to credit his work”)

(emphasis added)). Accordingly, we find that Exhibit 2015 supports heavily

Patent Owner’s assertion that there was industry praise for the system set

forth in Jaffray 2002.

Finally, Patent Owner cites Dr. Hashemi’s testimony that “Jaffray

2002 has been cited by more than 1,000 other scientific articles.” PO

Resp. 54‒55 (citing Ex. 2080 ¶¶ 75, 200‒201).15 More specifically, Dr.

Hashemi testifies that this conclusion is based “on a Google Scholar search

conducted by me on September 24, 2016.” Ex. 2080 ¶ 75. Petitioner does

not challenge this assertion. See generally Pet. Reply 17–18. We find that

this assertion supports heavily Patent Owner’s assertion that there was

industry praise for the system set forth in Jaffray 2002.

b. Petitioner’s Patented Radiation Therapy System

Patent Owner asserts that industry praise of Petitioner’s “patented

radiation therapy system,” embodied in U.S. Patent No. 7,945,021 (“the ’021

patent”), supports their assertion concerning industry praise of the invention

set forth in the challenged claims. PO Resp. 56 (citing Ex. 2014, 31:10–

32:22; Ex. 2080 ¶ 77). We have reviewed Patent Owner’s assertions and

supporting evidence, and we determine that Patent Owner has not

established the required analysis concerning the nexus between the system

set forth in Petitioner’s ’021 patent and independent claims 1, 7, 20, and 26.

At best, Exhibit 2014 accounts generally, concerning the ’021 patent, for

15 Patent Owner also cites paragraphs 76, 79, 202‒203, 289, 293 of Dr. Hashemi’s Declaration as identifying further industry praise of the system set forth in Jaffray 2002. PO Resp. 56. The content of those paragraphs are subsumed within the analysis of the “1,000 other scientific articles.”

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“[t]he addition of onboard cone-beam CT and flat-panel imaging, and

integration with a treatment machine.” Ex. 2014, 32:10–12. That citation,

however, does not account adequately for “wherein said computer receives

said three-dimensional information and based on said three dimensional

information received controls a path of said beam of radiation through said

object by controlling a relative position between said radiation source and

said object,” as recited by independent claim 1 and similarly recited by

independent claim 7, 20, and 26.

c. Petitioner’s On-Board Imager and Clinac/Trilogy Linear Accelerators

Patent Owner asserts that industry praise of the combination of

Petitioner’s On-Board Imager and each of Petitioner’s Clinac and Trilogy

linear accelerators support their assertion concerning industry praise of the

invention set forth in independent claims 1, 7, 20, and 26. PO Resp. 56

(citing Ex. 2052, WBH_Elekta_01164; Ex. 2054, WBH_Elekta_01198;

Ex. 2080 ¶¶ 260, 262). For nexus, Patent Owner asserts that the

aforementioned combination of Petitioner’s products meets every limitation

of independent claims 1, 7, 20, and 26. PO Resp. 59–61 (citing Ex. 2080

¶¶ 250‒258).16 Petitioner disagrees, asserting (1) Petitioner’s

aforementioned products include “many functionalities beyond the

challenged claims,” and (2) at least some of Petitioner’s aforementioned

products were successful without CBCT or three-dimensional (“3D”)

16 Although this portion of the Patent Owner Response also addresses the nexus between Petitioner’s TrueBeam system and independent claim 1 (PO Resp. 59–61 (citing Ex. 2080 ¶¶ 266–272)), the portion of the Patent Owner Response directed to industry praise does not provide evidence concerning industry praise for the TrueBeam system.

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imaging, as required by independent claim 1. Pet. Reply 18, 22–23 (citing

Ex. 1500 ¶¶ 76, 80, 81; Ex. 1502, 166:25–167:3; Exs. 1509–1511; Ex. 1515,

6; Ex. 2056, WBH_Elekta_01359). As an initial matter, we discern that

Petitioner’s assertion (1) goes more to the weight to be accorded the

evidence, as opposed to nexus.17

For assertion (2), after reviewing the evidence, we discern that the key

is whether or not the praise directed to the aforementioned product was

before or after approximately November 3, 2004. More specifically,

Petitioner asserts, and we agree, that prior to November 3, 2004, the

aforementioned product did not have either CBCT or 3-D imaging

capabilities, as required by independent claims 1, 7, 20, and 26, and, thus,

did not have a nexus with the challenged independent claims. Pet. Reply 22.

In particular, we find that the evidence shows that the aforementioned

product launched at or around March 3, 2004 (Ex. 1509) without either

CBCT or 3-D imaging capabilities, and that such capability was added at or

around November 3, 2004 (Ex. 1510). Consequently, we find that

subsequent to November 3, 2004, the aforementioned products did meet,

and, thus, had a nexus with, independent claims 1, 7, 20, and 26.

With that in mind, we evaluate Exhibit 2054, entitled “Varian Medical

Systems 2006 Annual Report.” As an initial matter, we find that Exhibit

17 When broad claims capture a single (or multiple) commercial embodiment(s), nexus is presumed. See ClassCo, 838 F.3d at 1222 (nexus presumed when the commercial “products embodied the claimed features” and the “Board’s blanket dismissal of it was in error”). In this situation, the Board must evaluate the evidence “taking into account the degree of the connection between the features presented in the evidence and the elements recited in the claims.” See ClassCo, 838 F.3d at 1221 (explaining that “[t]here is no hard-and-fast rule for this calculus”).

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2054 is directed to products sold during fiscal year 2006 which, under any

definition of fiscal year, is well after November 3, 2004. Ex. 2054,

WBH_Elekta_01198; accord Ex. 2052, WBH_Elekta_01187 (fiscal year

2005 ran from October 1, 2004 to September 30, 2005). Thus, the relevant

products referenced in Exhibit 2054 have a nexus with independent claims 1,

7, 20, and 26.

Moving on, Patent Owner identifies (PO Resp. 56 (citing Ex. 2080

¶ 262)) the following two portions of Exhibit 2054 as support for its

assertions concerning industry praise of Petitioner’s aforementioned product:

Varian’s On-Board Imager® device for image-guided radiotherapy (IGRT) and image-guided radiosurgery (IGRS) is a hit with customers around the world, and it was among the top 100 new product designs recognized by R&D magazine in 2006.

Ex. 2054, WBH_Elekta_01198.

Leadership in image-guided radiation therapy. The On-Board Imager® device earned an “R&D 100” award from R&D magazine as one of the most technologically significant products of the last year.

Ex. 2054, WBH_Elekta_01201. Petitioner asserts that the evidence is at

least somewhat undercut because the referenced products include “many

functionalities beyond the challenged claims.” Pet. Reply 18. We agree

with both parties to an extent. Specifically, we find that Exhibit 2054 does

support Patent Owner’s assertion of industry praise for the referenced

product, in that the key feature praised was image-guided radiation therapy

using an On-Board Imager, which we find had CBCT or 3-D imaging

capabilities in 2006. We also find, however, that such support is somewhat

undercut by the fact that the referenced products had implementations, i.e.,

imaging capabilities other than CBCT or 3-D equivalent, that did not meet

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every limitation of independent claims 1, 7, 20, and 26. Accordingly, we

find that Exhibit 2054 supports moderately Patent Owner’s assertion that

there was industry praise for Petitioner’s aforementioned product.

d. Conclusion

In summary, we weigh Patent Owner’s proffered evidence of industry

praise as follows: (a) heavy weight to industry praise of Jaffray 2002; (b) no

weight to industry praise of Petitioner’s patented radiation therapy system;

and (c) moderate weight to industry praise of the combination of Petitioner’s

On-Board Imager and each of Petitioner’s Clinac and Trilogy linear

accelerators. When weighed in the aggregate, we find that Patent Owner has

proffered very strong evidence of industry praise for, and, hence, non-

obviousness of, the invention set forth in independent claims 1, 7, 20, and

26.

iii. Long-Felt Need

Establishing long-felt need first requires objective evidence that an art

recognized problem existed in the art for a long period of time without

solution. See In re Gershon, 372 F.2d 535, 539, (CCPA 1967); Orthopedic

Equipment Co., Inc. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 (Fed.

Cir. 1983). Second, the long-felt need must not have been satisfied by

another before the invention by applicant. Newell Companies v. Kenney

Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). Third, the invention must in

fact satisfy the long-felt need. In re Cavanagh, 436 F.2d 491. See also

Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1332-33 (Fed. Cir.

2009) (articulating all three factors).

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a. Recognized Need for Long Period of Time

Patent Owner asserts that there was a long-felt need for the following:

“how to accurately deliver the requisite dose to a soft-tissue tumor that

undergoes movement or displacement between treatment fractions.”

Ex. 2080 ¶ 72; see generally PO Resp. 57–58. As supporting evidence

concerning the need to be solved, Patent Owner cites McBain (Ex. 2071)

through Dr. Hashemi’s Declaration. Ex. 2080 ¶¶ 285–290. Most

pertinently, McBain discloses the following:

Current standard methods of treatment verification rely on the acquisition of two-dimensional (2D) electronic megavoltage portal images (EPIs), which demonstrate bony anatomy but do not provide soft-tissue definition. This means that although EPIs can be compared with a reference image to correct for setup errors, they do not assess internal organ motion.

The measurement of position and shape of soft-tissue target structures, at the point of treatment delivery, has been the subject of study by a number of investigators. Since the early 1990s, there has been much interest in the use of the portal imaging system to provide megavoltage (MV) projection images that can be reconstructed using cone beam reconstruction algorithms (5). This technology has progressed considerably but is fundamentally limited by detector sensitivity, which means imaging doses are as high as 5% of the fraction dose (6) and the inherent inability of megavoltage X-rays to discriminate the contrast due to density differences between soft-tissue structures such as muscle and fat.

Ex. 2071, WBH_Elekta_01463.

Petitioner asserts that under cross-examination, Dr. Hashemi

narrowed the need to be solved to “acquiring a volumetric image with soft-

tissue contrast at the time of treatment.” Ex. 1500 ¶ 78; see Pet. Reply 19–

20 (citing Ex. 1500 ¶ 78 (citing Ex. 1502, 155:25–156:12)). We disagree.

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The full exchange between Petitioner’s counsel and Dr. Hashemi is set forth

below:

Q. So what I’m trying to figure out is, what problem exactly was solved by the ’502 patent, in your opinion?

A. The ability to acquire a volumetric image, see the soft tissues within that volumetric image at the time of treatment, be able to see what organs are being treated under the beam, whether the target that is intended to be treated is in the right position and have the surrounding organs at risk, have they gone through any changes or movement that now they are in danger of becoming subject to radiation. These are all the solutions that IGRT provides.

Ex. 1502, 155:25–156:12.18 We discern that Dr. Hashemi’s testimony here

more accurately supports Patent Owner’s formulation of long-felt need, and

not Petitioner’s prematurely truncated version.

Petitioner also asserts that McBain should be discounted because it

was “supported by an educational grant from Elekta (Crawley, United

Kingdom).” Pet. Reply 19 (quoting Ex. 2071, WBH_Elekta_01462). The

implication, of course, is that McBain was biased toward overstating the

need articulated and solution provided. While Petitioner’s assertion has

some merit, especially with regards to the adequacy of the solution provided,

we are unpersuaded that it casts doubt on the articulation of the need to be

solved, as set forth in McBain. Furthermore, as noted by Dr. Hashemi,

“Exhibit 2071 is a peer-reviewed article entitled X-ray Volumetric Imaging

in Image-Guided Radiotherapy: The New Standard in On-Treatment

Imaging, authored by Catherine A. McBain and co-workers at Christie

18 Although the question posed to Dr. Hashemi was with respect to the ’502 patent, the same question and response from Dr. Hashemi is equally relevant to the ’765 patent.

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Hospital and published in the International Journal of Radiation Oncology

Biology & Physics in 2006.” Ex. 2080 ¶ 287. We discern that such

independent indicia of reliability mitigate at least somewhat against any

biased impugned to McBain by Patent Owner’s funding.

Accordingly, when all of the above is considered in the aggregate, we

find that the aforementioned portion of McBain supports adequately Patent

Owner’s assertion as to the articulation of the need to be solved, and that it

was long-felt at least since “the early 1990s.” Ex. 2071,

WBH_Elekta_01463.

b. Not Satisfied Earlier by Another

By asserting that Patent Owner was the first to satisfy the

aforementioned long-felt need, Patent Owner is implicitly asserting that the

need was not satisfied earlier by another. See generally PO Resp. 57–58.

Petitioner asserts that at least the work of three others, Jaffray 1997

(Ex. 1107), Simpson, and fan-beam techniques, had earlier satisfied the

aforementioned long-felt need. Pet. Reply 19‒20.

Beginning with Jaffray 1997, Petitioner asserts that “Patent Owner

also focuses on the article titled ‘X-Ray Volumetric Imaging in Image-

Guided Radiotherapy’ (see Ex. 2080, ¶ 287), ignoring the fact that this title

actually describes the prior art disclosures of, for example, Jaffray 1997.”

Pet. Reply 19‒20. Petitioner does not provide any further analysis in

support of this assertion, however, and without such analysis, we are

unpersuaded by Petitioner.

Regarding Simpson, Petitioner appears to be referring to the following

sentence in Dabaja: “Cone-beam CT was originally explored by Simpson et

al. [6] as a way of generating single-slice tomograms with one gantry

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rotation of the linear particle accelerator (LINAC).” Ex. 2072,

WBH_Elekta_01474. We are unpersuaded as the aforementioned citation

refers to “single-slice tomograms,” while independent claim 1 recites “an

image that contains three-dimensional information,” and independent claims

7, 20, and 26 each recite substantially similar limitations. Petitioner has not

shown adequately whether the “single-slice tomogram” of Simpson includes

such “three dimensional information.”19

Concerning fan-beam techniques, Petitioner cites the following

portion of Exhibit 2033: “kV CBCT offers high-resolution images with

lower soft tissue contrast compared to fan-beam CTs due to scattered X-rays

reaching the flat panel detector, however CBCTs generally deliver less dose

due to differences in filtration techniques and lower photon fluences.”

Ex. 2033, WBH_Elekta_00816. While we acknowledge that, in view of the

above-articulated need, higher soft tissue contrast would appear to be

preferable, Petitioner has not explained sufficiently why the soft tissue

contrast in the CBCT image would have been inadequate to meet Patent

Owner’s articulated need.

Based on the above, we find that the evidence provided does not

indicate that the aforementioned need was satisfied earlier by another.

c. Nexus of Proposed Solution

Patent Owner asserts that their Synergy System was both the proposed

solution to the aforementioned problem, and coextensive with independent

19 Dabaja discloses later in that paragraph “[a] volumetric CT image is reconstructed from data collected during a single gantry rotation.” Ex. 2072, WBH_Elekta_01475. That disclosure, however, is not concerning Simpson.

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claim 120 of the ’765 patent. PO Resp. 57–58 (citing Ex. 2080 ¶¶ 222‒229,

285–294). Other than asserting that Patent Owner’s Synergy System

includes features not articulated in independent claims 1, 7, 20, and 26, an

assertion we discern goes to weight, and not nexus, Petitioner does not

dispute either of the above assertions. See generally Pet. Reply 19–20.

After reviewing Patent Owner’s assertions, as well as the relevant analysis

of Dr. Hashemi, we find that Patent Owner’s Synergy System meets all the

limitations of, and, thus, has a nexus with, independent claim 1.

d. Whether Proposed Solution Satisfies Need

Patent Owner asserts that the above-proposed solution satisfies the

aforementioned need. PO Resp. 58 (citing Ex. 2080 ¶¶ 287–293). In

particular, Patent Owner asserts that “[t]he ’765 patent solved this problem

by creating 3-D tomographic images of the target volume at the time of

treatment that were of sufficient quality to permit significant reduction in the

treatment margins.” PO Resp. 58. In support, Patent Owner cites a

prediction from McBain for such success (Ex. 2071, WBH_Elekta_01463),

as well as an example of a successful treatment using the proposed solution.

PO Resp. 58 (citing Ex. 2080 ¶¶ 291–293 (discussing Ex. 2072,

WBH_Elekta_01473–75)).

Petitioner asserts that Patent Owner’s proposed solution is inadequate,

because “even today kV CBCT methodologies have not ‘solved’ the tumor

targeting problem.” Pet. Reply 19. For support, Petitioner cites the

following portion of Exhibit 2033: “Unfortunately, IGRT strategies cannot

completely correct for patient setup errors and considerable CTV-to-PTV

20 Independent claims 7, 20, and 26 recite substantially similar limitations, and, therefore, we apply our analysis to all of the independent claims.

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margins are still required due to large internal organ motion in prostate

patients.” Ex. 2033, WBH_Elekta_00814. We determine that Petitioner

overstates their assertion, in that we do not read the aforementioned

disclosure of Exhibit 2033 as asserting that CBCT is an inadequate solution

to the aforementioned need. Instead, we discern it merely states the

unremarkable proposition that further improvement is desirable.

Petitioner asserts further that McBain should be discounted because it

was “supported by an educational grant from Elekta (Crawley, United

Kingdom),” and it only opines as to a prediction concerning potential

usefulness of Patent Owner’s Synergy System. Pet. Reply 19–20 (citing

Ex. 2071, WBH_Elekta_01462). Generally, we agree with Petitioner,

although we note that any bias imputed to McBain from Patent Owner’s

funding is at least somewhat mitigated by independent indicia of reliability

referenced above concerning our discussion of “Recognized Need for Long

Period of Time.”

Petitioner asserts also that “Patent Owner’s reference to the use of 3-D

CBCT in a specific individual patient case report (see id., ¶¶ 288–289) does

not prove a general solution to a long-felt need.” Pet. Reply 20. As an

initial matter, we note that Petitioner does not dispute that Exhibit 2072 sets

forth a solution to the aforementioned need, and there appears to be nexus, in

that Exhibit 2072 discloses using Petitioner’s “cone-beam CT device

equipped with on-board imaging,” which has a nexus with independent

claims 1, 7, 20, and 26 for the reasons set forth above. Moreover, we are

unclear as to why one “specific individual patient case report” cannot be a

sufficient basis to “prove a general solution to a long-felt need,” especially

where the solution articulated in the “specific individual patient case report”

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both acknowledges expressly and appears to adequately resolve the long-felt

need. See e.g., Ex. 2072, WBH_Elekta_01474–75 (“Before the era of

3DCRT, the abdominal mass in this patient would have been missed in the

course of daily treatments. Our use of cone-beam CT with on-board

imaging capability was extremely useful in this case and allowed us to

successfully treat this patient . . . . We conclude from this experience that

image-guided radiation therapy is both valid and useful for tracking the

motion of highly mobile abdominal masses.”)

Accordingly, in summary, even when we discount heavily McBain for

the reasons set forth above, we discern that Patent Owner has shown

sufficiently that their proffered solution satisfies the aforementioned long-

felt need.

e. Conclusion

In summary, we find that Patent Owner has provided sufficient

supporting evidence and analysis to show adequately that (1) there was a

recognized long-felt need, (2) the need was not earlier satisfied by another,

and (3) Patent Owner’s proffered solution satisfied that need. When

weighed in the aggregate, we find that Patent Owner has proffered very

strong evidence of long-felt need for, and, hence, non-obviousness of, the

invention set forth in independent claims 1, 7, 20, and 26.

iv. Commercial Success

a. Patent Owner’s Synergy, Infinity, and Versa HD Systems

Patent Owner asserts the following concerning the commercial

success of their Synergy, Infinity, and Versa HD Systems:

William Beaumont Hospital has exclusively licensed the ’765 patent to Elekta, who has paid approximately $40 million in

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licensing fees since 2003. (Ex. 2083 ¶ 3; Ex. 2080 ¶ 249). Under that license, Elekta has sold its Synergy XVI, Infinity, and Versa HD systems, which are medical linear accelerators with an integrated CBCT-FPI system embodying the Challenged Claims and are coextensive with them. (Id. ¶¶ 222–248). Elekta’s Synergy XVI, Infinity, and Versa HD systems have been commercially successful, and they now represent more than 85 percent of the linear accelerators Elekta sells. (Ex. 2048 ¶ 4; Ex. 2080 ¶ 249).

PO Resp. 59.

Starting with nexus between Patent Owner’s Synergy, Infinity, and

Versa HD systems and independent claim 1,21 Patent Owner relies on the

testimony and analysis of Dr. Hashemi. Ex. 2080 ¶¶ 222–248. Petitioner

asserts that Patent Owner’s nexus is flawed, because the aforementioned

systems include many unclaimed features, and can be used in ways that do

not have relevance to the limitations of independent claim 1. Pet. Reply 20‒

21. As noted above, we discern that this assertion goes to weight, and not

nexus. Accordingly, after reviewing Patent Owner’s assertions, as well as

the relevant analysis of Dr. Hashemi, we find that Patent Owner’s Synergy,

Infinity, and Versa HD systems each meet all the limitations of, and, thus,

have a nexus with, independent claim 1.

With nexus addressed, we next turn to the relevant evidence,

beginning with Exhibit 2048. Petitioner’s above assertion concerning

additional features is relevant to the amount of weight to be accorded

Exhibit 2048 concerning the commercial success of Patent Owner’s

Synergy, Infinity, and Versa HD systems. To that end, we agree with

21 Independent claims 7, 20, and 26 recite substantially similar limitations, and, therefore, we apply our analysis to all of the independent claims.

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Petitioner that the weight to be accorded Exhibit 2048 should be discounted

somewhat in that regard. More specifically, we agree that in a machine as

complex as Patent Owner’s systems, commercial success would have been

driven by many features and considerations, of which the features

coextensive with independent claim 1 would certainly have been a factor,

however, absent further elaboration by Patent Owner, we also discern that it

could not have been the only factor driving commercial success.

Relatedly, we discern that Patent Owner’s evidence should be further

discounted because Patent Owner admits that only 85% of their linear

accelerators installed in the United States include CBCT capability,

indicating that 15% do not have a nexus with independent claim 1.

Ex. 2048, WBH_Elekta_01153–54. Indeed, we note that Patent Owner’s

Declarant, Mr. Jaime Gonzalez, admits further that “[t]he linear accelerators

that can be equipped with these XVI systems include the Synergy, Infinity,

Axesse and Versa HD linear accelerators.” Ex. 2048, WBH_Elekta_01145

(emphasis added). Without further analysis that the aforementioned systems

were equipped with CBCT capability, we discount further Patent Owner’s

evidence in that regard, although the amount discounted is somewhat

mitigated by Patent Owner’s assertion, with which we are in agreement, that

in order to show commercial success, “you don't have to have a product that

completely supplants the market by a hundred percent. You just have to

show that the product was commercially successful. And it certainly was

here because the majority worldwide and almost all of them in North

America were sold with this functionality.” Tr. 43:8–14.

Finally, we additionally discount Exhibit 2048 because Patent Owner

includes in the 85% their Axesse system. Ex. 2048, WBH_Elekta_01153.

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As set forth above, Mr. Gonzalez purports that Patent Owner’s Axesse linear

accelerator can also be equipped with CBCT capability. This is the first

mention of the relevance of Patent Owner’s Axesse system, and neither

Patent Owner nor Dr. Hashemi indicates that they compared the Axesse

system to independent claim 1. See generally PO Resp. 59; Ex. 2080

¶¶ 244‒248. Nevertheless, Patent Owner appears to have included the

Axesse system in the 85%. Accordingly, Patent Owner’s aforementioned

evidence is further discounted for this reason.

Petitioner asserts further that “the sales data is insufficient because

Patent Owner has provided no evidence establishing the importance of these

sales in the relevant market.” Pet. Reply 21. We agree with Petitioner that

Exhibit 2048 should be discounted heavily for those reasons.

Along similar lines, turning next to Exhibit 2083, Petitioner asserts

that Patent Owner’s licensing evidence should be discounted heavily for the

following reasons:

The license in question admittedly relates to three separate patents, only one of which is at issue in this case, and no contextual evidence is provided to explain why the license was taken or to tie any aspect of it to the claims. Concerns about this lack of context, and the knowledge that licenses may be taken for many reasons unrelated to patentability is why “the mere existence” of licenses, “without more specific information about the circumstances surrounding the licensing, is often not a good indicator of nonobviousness.” See Cisco [Sys., Inc. v. Crossroads Sys., Inc., IPR2014-01463, Paper 49 at 36 (PTAB Mar. 16, 2016)].

Pet. Reply 21‒22. Again, we are in agreement with Petitioner for these

reasons.

In summary, for the reasons set forth above, we discount almost

entirely the weight to be accorded Exhibit 2048, and discount heavily the

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weight to be accorded Exhibit 2083. Accordingly, after considering all of

Patent Owner’s assertions and evidence in the aggregate, in view of

Petitioner’s assertions, we find that Patent Owner has provided very weak

evidence of commercial success of their Synergy, Infinity, and Versa HD

systems.

b. Petitioner’s On-Board Imager and Clinac/Trilogy Linear Accelerators

Patent Owner asserts the following concerning the commercial

success of Petitioner’s On-Board Imager and Clinac/Trilogy linear

accelerators:

Petitioner Varian’s Clinac and Trilogy lines of linear accelerators equipped with a CBCT-FPI system (the “On-Board Imager”) have likewise been commercially successful. As Dr. Bani-Hashemi notes, these linear accelerators meet the limitations of the independent Challenged Claims. (Ex. 2080 ¶¶ 250–258). Petitioner publicized that after the first installation in 2005, demand for its On-Board Imager was “overwhelming” and “exceeded . . . expectations.” (Id. ¶ 259). In fact, order volume for Varian’s On-Board Imager grew by more than 70 percent from 2005 to 2006, a rate of adoption three times greater than Varian experienced with its prior product lines. (Id. ¶¶ 261‒263). By 2007, over 70% of [Petitioner’s] linear accelerators sold were equipped with a CBCT-FPI system. (Id. ¶ 264). . . . The commercial successes of Varian’s On-Board Imager and TrueBeam systems are attributable to the claimed features of the ’765 patent. (Id. ¶¶ 265, 272, 283‒284).

PO Resp. 59‒60. For nexus, for the same reasons set forth above in

addressing industry praise, we find that subsequent to November 3, 2004,

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the aforementioned products did meet, and, thus, had a nexus with,

independent claim 1.22

With that in mind, Patent Owner first identifies, through

Dr. Hashemi’s Declaration, Exhibit 2051, which is a press release dated

August 1, 2005, and entitled “Varian Medical Systems Reports Rapid

Adoption of On-Board ImagerTM Device for Image-Guided Radiotherapy.”

PO Resp. 59‒60 (citing Ex. 2080 ¶ 259 (discussing Ex. 2051)). In Exhibit

2051, Patent Owner identifies two disclosures as supporting their assertion

concerning the commercial success of Petitioner’s aforementioned products:

Varian Medical Systems today announced that it is experiencing robust demand for its Image Guided Radiation Therapy (IGRT) products. The company reports that it has now installed or commenced installation of more than 80 of its new On-Board ImagerTM devices, a technology that enhances treatment precision.

Ex. 2051, WBH_Elekta_01157 “It’s clear that radiation oncology is rapidly embracing

IGRT as a crucial aid to enhancing the accuracy, effectiveness and reach of radiotherapy . . . . We have seen this new imaging technology take off very quickly. . . . The first On-Board Imager was installed at Sweden’s Karolinska Institute in Stockholm a year ago, and since then there has been an overwhelming demand that has exceeded our expectations.”

Ex. 2051, WBH_Elekta_01157 (quotation from Petitioner’s Chief Operating

Officer). Petitioner asserts that Patent Owner has failed to show nexus

between the commercial success of the aforementioned products and

independent claim 1. Pet. Reply 22. We largely agree with Petitioner.

22 Independent claims 7, 20, and 26 recite substantially similar limitations, and, therefore, we apply our analysis to all of the independent claims.

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Exhibit 2051 is dated August 1, 2005, and as set forth above, we find that

the aforementioned products sold after November 3, 2004 had a nexus with

independent claim 1. Accordingly, at an initial glance, the products

referenced in Exhibit 2051 would appear to have a nexus with independent

claim 1. On closer inspection, however, Exhibit 2051 refers to installed On-

Board Imager Devices, and that “[t]he first On-Board Imager was installed

at Sweden’s Karolinska Institute in Stockholm a year ago.” Ex. 2051,

WBH_Elekta_01157 (emphasis added). Both quotations refer to past

systems, and given that the August 1, 2005 date of Exhibit 2051 is not so far

removed from November 3, 2004, we discern that it was necessary for

Patent Owner to provide some explanation as to how many of the

aforementioned products were installed on or after November 3, 2004.

Absent such an explanation by Patent Owner, we agree with Petitioner that it

is unclear how many of the aforementioned products were installed prior to

November 3, 2004, and, thus, would not have a nexus with independent

claim 1. For these reasons, we discount heavily the weight to be accorded

Exhibit 2051 in support of Patent Owner’s assertions, and, accordingly, find

that Exhibit 2051 is weak evidence of the commercial success of Petitioner’s

aforementioned products.

Patent Owner next identifies Exhibit 2052 in support of its assertion.

PO Resp. 56, 59‒60 (citing Ex. 2080 ¶ 260 (discussing Ex. 2052)). Exhibit

2052 is entitled “VARIAN 05: Varian Medical Systems 2005 Annual

Report,” and accounts for data during Fiscal Year 2005, which Exhibit 2052

discloses as running from October 1, 2004 to September 30, 2005.

Ex. 2052, WBH_Elekta_01167, WBH_Elekta_01195. In Exhibit 2052,

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Patent Owner identifies the following disclosure as supporting their assertion

concerning the commercial success of Petitioner’s aforementioned products:

A new process, known as image-guided radiation therapy (IGRT), has been hailed as a technological breakthrough. We have led the field in practical implementation of this technology with more than 275 orders and 110 shipments of automated, robotically controlled On-Board Imager devices for IGRT since their introduction in fiscal 2004. . . . By the end of fiscal 2005, Varian had received more than 275 orders for On-Board ImagerTM devices for either Clinac® or TrilogyTM accelerators.

Ex. 2052, WBH_Elekta_01164, WBH_Elekta_01168. Petitioner asserts that

Patent Owner has failed to show a nexus between the commercial success of

the aforementioned products and independent claim 1. Pet. Reply 22. For

similar reasons set forth above with respect to Exhibit 2051, we largely

agree with Petitioner. In short, the relevant order and shipment numbers

from Exhibit 2052 include products ordered/shipped in fiscal year 2004, of

which none would have had a nexus with independent claim 1, and at least a

part of fiscal year 2005 is prior to November 3, 2004, and, thus, at least

some of the products ordered/shipped in fiscal year 2005 do not have a

nexus with independent claim 1. For these reasons, we discount heavily the

weight to be accorded Exhibit 2052 in support of Patent Owner’s assertions,

and, accordingly, find that Exhibit 2052 is also weak evidence of the

commercial success of Petitioner’s aforementioned products.

Patent Owner also identifies Exhibit 2053, which is a press release

dated July 27, 2006, and entitled “Varian Medical Systems Reports Rapid

Adoption of the Company’s Technology for Image-Guided Radiotherapy.”

PO Resp. 59‒60 (citing Ex. 2080 ¶ 261 (discussing Ex. 2053)). In Exhibit

2053, Patent Owner identifies the following disclosure as supporting their

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assertion concerning the commercial success of Petitioner’s aforementioned

products:

“We are seeing tremendous demand for our image-guided radiotherapy machines with the On-Board Imager—both at freestanding clinics as well as at hospitals and large academic centers . . . . IGRT is clearly moving into the medical mainstream. Because the On-Board Imager yields two-dimensional images, 3-D cone-beam CT images, and fluoroscopic moving images, it’s the most versatile IGRT tool available and doctors have been capitalizing on all of those capabilities to enhance the quality of patient care.”

Ex. 2053, WBH_Elekta_01191 (quoting Petitioner’s President and CEO).

Petitioner asserts that Patent Owner has failed to show a nexus between the

commercial success of the aforementioned products and independent claim

1. Pet. Reply 22. We disagree. Unlike Exhibits 2051 and 2052, Exhibit

2053 is dated well after November 3, 2004, and, indeed, even mentions

expressly “3-D cone-beam CT images.” Thus, we find that Exhibit 2053 has

a nexus with independent claim 1.

Petitioner asserts that the weight accorded to Exhibit 2053 should be

discounted because “Patent Owner’s expert . . . incorrectly assumed that the

Clinac+OBI product had full rotation CBCT capability when it was

launched” (Ex. 1502, 166:25–167:3). Pet. Reply 22. We agree that the

weight should be discounted somewhat for these reasons. Accordingly, we

find that Exhibit 2053 is some evidence of the commercial success of

Petitioner’s aforementioned products.

Patent Owner further identifies Exhibit 2054 in support of its

assertion. PO Resp. 59‒60 (citing Ex. 2080 ¶¶ 262–263 (discussing

Ex. 2054)). Exhibit 2054 is entitled “Varian Medical Systems 2006 Annual

Report,” and accounts for data during Fiscal Year 2006, which we found

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above encompasses a time period well after November 3, 2004. Ex. 2054,

WBH_Elekta_01194. Patent Owner identifies the following disclosures as

supporting their assertion concerning the commercial success of Petitioner’s

aforementioned products:

This X-ray imaging accessory for improving the precision and effectiveness of treatments was included in more than 60 percent of the orders we received during the year for our high-energy Clinac® and Trilogy® linear accelerators.

Ex. 2054, WBH_Elekta_01198.

IGRT adoption is occurring three times faster than what we experienced with the introduction of our highly successful products for intensity-modulated radiation therapy (IMRT) earlier this decade.

Ex. 2054, WBH_Elekta_01198.

Order volume for the powerful and ultraprecise Trilogy linear accelerator for both radiotherapy and radiosurgery grew by more than 70 percent to more than 85 units.

Ex. 2054, WBH_Elekta_01201. Petitioner asserts that Patent Owner has

failed to show a nexus between the commercial success of the

aforementioned products and independent claim 1. Pet. Reply 22. We

disagree. Unlike Exhibits 2051 and 2052, Exhibit 2054 is dated well after

November 3, 2004. Thus, we find that Exhibit 2054 has a nexus with

independent claim 1.

Petitioner asserts tangentially that the weight accorded to

Exhibit 2054 should be discounted because “because of a lack of nexus.”

Pet. Reply 20‒21. We agree that the weight should be discounted slightly

for these reasons. Accordingly, we find that Exhibit 2054 is moderately

strong evidence of the commercial success of Petitioner’s aforementioned

products.

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Patent Owner additionally identifies Exhibit 2055 in support of its

assertion. PO Resp. 60 (citing Ex. 2080 ¶ 264 (discussing Ex. 2055)).

Exhibit 2055 is a Form 10K Annual Report for Varian Medical Systems,

Inc. submitted on November 26, 2007. Ex. 2055, WBH_Elekta_01214,

WBH_Elekta_01348. Patent Owner identifies the following disclosures as

supporting their assertion concerning the commercial success of Petitioner’s

aforementioned products:

We are seeing customers accept IGRT as the next significant enhancement in curative radiation therapy, and demand for our products for IGRT has been one of the main contributors to net orders and revenue growth in our Oncology Systems business segment.

Ex. 2055, WBH_Elekta_01231.

Nearly all of our high energy accelerators ordered in North America and over 70% of high energy accelerators ordered worldwide during fiscal year 2007 were ordered with our On-Board Imager product, or OBI, which enables IGRT.

Ex. 2055, WBH_Elekta_01257. Petitioner asserts that Patent Owner has

failed to show a nexus between the commercial success of the

aforementioned products and independent claim 1. Pet. Reply 22. We

disagree. Unlike Exhibits 2051 and 2052, Exhibit 2055 is dated well after

November 3, 2004. Thus, we find that Exhibit 2055 has a nexus with

independent claim 1.

Petitioner asserts tangentially that the weight accorded to Exhibit

2055 should be discounted because “because of a lack of nexus.” Pet. Reply

20. We agree that the weight should be discounted slightly for these

reasons. Accordingly, we find that Exhibit 2055 is moderately strong

evidence of the commercial success of Petitioner’s aforementioned products.

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In summary, for the reasons set forth above, we discount heavily the

weight to be accorded Exhibits 2051 and 2052, discount moderately the

weight to be accorded Exhibit 2053, and discount slightly the weight to be

accorded Exhibits 2054 and 2055. Accordingly, after considering all of

Patent Owner’s assertions and evidence in the aggregate, in view of

Petitioner’s assertions, we find that Patent Owner has provided moderately

strong evidence of commercial success of Petitioner’s aforementioned

products.

c. Petitioner’s TrueBeam Linear Accelerator Patent Owner asserts the following concerning the commercial

success of Petitioner’s TrueBeam linear accelerators:

Varian experienced similar “overwhelmingly positive” customer response to its TrueBeam linear accelerator, the introduction of which Varian described as, among other superlatives, “the most successful launch of a medical linear accelerator” in its history. (Id. ¶¶ 273–283). As Dr. Bani-Hashemi explains, Varian’s TrueBeam linear accelerator also meets the limitations of the independent Challenged Claims. (Id. ¶¶ 266–272). The commercial successes of Varian’s On-Board Imager and TrueBeam systems are attributable to the claimed features of the ’765 patent. (Id. ¶¶ 262, 272, 283–284).

PO Resp. 60.

For nexus, Patent Owner asserts that the aforementioned combination

of Petitioner’s products meets every limitation of independent claim 1.

PO Resp. 60 (citing Ex. 2080 ¶¶ 266–283). Petitioner disagrees, asserting

the following:

Patent Owner’s attempt to encircle Varian’s TrueBeam product within its nonobviousness arguments also fails. First, TrueBeam is a highly complex product with many unique features (none of which are germane to the limitations of the challenged claims) that are not present on Clinac+OBI. (See Ex.

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1500, ¶ 82.) Second, Patent Owner is mistaken when it again assumes that all uses of the TrueBeam imaging system are pertinent to the limitations of the claims. To the contrary, as with Clinac+OBI, Patent Owner’s evidence shows that TrueBeam imaging includes “kV planar” and “fluoroscopic imaging” modes that have no nexus to any limitation of the claims. (See Ex. 2056 at WBH_Elekta_01359.)

Pet. Reply 22‒23. We discern that Petitioner’s assertions are relevant to the

weight to be accorded the evidence of commercial success, and not nexus.

Based on the above, we find that Patent Owner has shown the Petitioner’s

TrueBeam linear accelerator includes every limitation of, and, thus, has a

nexus with, independent claim 1.

Having said that, we acknowledge that Patent Owner references

Exhibits 2061–2070 at paragraphs 273–282 of Dr. Hashemi’s Declaration.

We further acknowledge that page 60 of the Patent Owner Response

references paragraphs 273–282 of Dr. Hashemi’s Declaration, as follows:

“Varian experienced similar ‘overwhelmingly positive’ customer response to

its TrueBeam linear accelerator, the introduction of which Varian described

as, among other superlatives, ‘the most successful launch of a medical linear

accelerator’ in its history. (Id. ¶¶ 273–283).” Thus, it would appear that

based on this one line of argument in the Patent Owner Response, Patent

Owner would like the Board to consider and evaluate in detail, with no

further guidance in the Patent Owner Response, the disclosures of Exhibits

2061–2070 as it relates to their above assertion. We decline to do so, as we

determine that this represents an impermissible attempt by Patent Owner to

circumvent the page limits for this proceeding by incorporating, by

reference, substantive arguments concerning Exhibits 2061–2070, and

paragraphs 273–283 of Dr. Hashemi’s Declaration, that should have been set

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forth in the Patent Owner Response. See 37 C.F.R. § 42.6(a)(3)

(“Arguments must not be incorporated by reference from one document into

another document.”) Thus, we determine that for these reasons, Patent

Owner has, effectively, not advanced any evidence to support their

assertions concerning the commercial success of Petitioner’s TrueBeam

linear accelerator.

For these reasons, we find that Patent Owner has provided no

evidence of commercial success of Petitioner’s aforementioned product.

d. Industry-Wide Commercial Success Patent Owner asserts the following:

Given the widespread clinical adoption of using a CBCT-FPI system for image-guided radiation therapy, it is no surprise that Elekta’s Versa HD and Varian’s TrueBeam linear accelerators all come equipped with these imaging systems, which were once add-ons. Even Dr. Balter acknowledged that, since the introduction of the ’765 patent, an integrated CBCT-FPI system has become a standard feature on most linear accelerators. (Ex. 2011 at 148:10–17, 149:15–150:9; Ex. 2080 ¶ 221). Accordingly, the industry-wide commercial success of linear accelerators equipped with CBCT-FPI systems weighs heavily in favor of nonobviousness. See Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000) (“Our case law provides that the success of an infringing product is considered to be evidence of the commercial success of the claimed invention.”).

PO Resp. 60–61.23 In particular, we find particularly relevant Dr. Balter’s

cross-examination testimony as follows:

23 As set forth above, we find that Patent Owner’s Versa HD and Petitioner’s TrueBeam linear accelerators account for each limitation of, and thus, have a nexus with, independent claim 1. See PO Resp. 59–60 (citing Ex. 2080 ¶¶ 222–248, 273–283).

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Q. And has the introduction of those products -- A. Uh-huh. Q. -- had a substantial impact on the field of radiation

therapy? MR. KNAUSS: Objection. Form. Foundation. THE WITNESS: So I would say that – that in-room

volumetric, in-room three-dimensional, in-room monitoring, all the advances in imaging have had a dramatic impact on the field.

Q. (BY MR. ROSENTHAL) Okay. And one of those advances was the introduction of on-board CBCT with flat-panel imaging by Varian and Elekta in the mid-2000s; correct?

MR. KNAUSS: Object to the form. THE WITNESS: One of those advances was the

commercial introduction of cone-beam CT on a linear accelerator.

Ex. 2011, 149:15–150:9. Petitioner asserts tangentially that the weight

accorded to evidence of industry-wide commercial success should be

discounted because “it contains several other unclaimed features,” such as

the “in-room monitoring” mentioned here by Dr. Balter. Pet. Reply 20‒21.

We agree that the weight should be discounted slightly for these reasons.

Accordingly, we find that Exhibit 2011 is moderately strong evidence of the

industry-wide commercial success of the claimed invention.

e. Conclusion In summary, we find that Patent Owner has provided (1) very weak

evidence of commercial success of their Synergy, Infinity, and Versa HD

systems, (2) moderately strong evidence of commercial success of

Petitioner’s OBI and Clinac/Trilogy linear accelerator, (3) no evidence of

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commercial success of Petitioner’s TrueBeam linear accelerator, and (4)

moderately strong evidence of the industry-wide commercial success of the

claimed invention, with particularly strong weight given to the

aforementioned portions of Exhibits 2011, 2054, and 2055. When weighed

in the aggregate, we find that Patent Owner has proffered moderately strong

evidence of commercial success of, and, hence, non-obviousness of, the

invention set forth in independent claim 1. As discussed above, independent

claims 7, 20, and 26 recite substantially the similar limitation and, therefore,

our analysis applies to these claims as well.

v. Copying

a. Thilmann Patent Owner asserts that Thilmann copied Jaffray 2002 as follows:

Thilmann and co-workers (Exs. 2034, 2035) modified a Siemens linear accelerator to incorporate a CBCT-FPI system for verification of tumor position while the patient is on the treatment table. (Ex. 2080 ¶¶ 205‒207). Thilmann’s linear accelerator meets each and every limitation of at least the independent Challenged Claims. (Id. ¶¶ 208–212). Thilmann praised “the acquisition of cone beam computed tomograph[y] at the linac with the patient in treatment position” as “[o]ne of the most prominent imaging techniques in image guided radiotherapy.” (Ex. 2035 at 62, Abstract; Ex. 2080 ¶¶ 213–214).

PO Resp. 61.24 For nexus, Patent Owner asserts that the aforementioned

combination of Petitioner’s products meets every limitation of independent

claim 1. PO Resp. 61 (citing Ex. 2080 ¶¶ 208–212). Petitioner disagrees,

asserting that Thilmann did not attribute their work to the copying of the

24 As set forth above, we find that Jaffray 2002 accounts for each limitation of, and thus, has a nexus with, independent claim 1. See PO Resp. 54–55 (citing Ex. 2080 ¶¶ 195–200).

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’765 invention. Pet. Reply 23. We discern that Petitioner’s assertions are

relevant to the weight to be accorded the evidence of copying, and not to

nexus. Based on the above, we find that Patent Owner has shown that the

system created by Thilmann includes every limitation of, and, thus, has a

nexus with, independent claim 1.

Petitioner asserts that the weight accorded to Exhibits 2034 and 2035

in support of Patent Owner’s assertions of copying should be discounted

because Thilmann did not expressly attribute their work to the copying of

the ’765 invention. Pet. Reply 23–24. We disagree. We find that Exhibit

2035 expressly cites Jaffray 2002 in support of the following disclosure:

“[f]or the radiation source, . . . as all common linac vendors presently

propose[,] one can integrate an additional kilovoltage (kV)-x-ray source with

the linac’s gantry.” Ex. 2035, WBH_Elekta_00829. We discern that

citation of a concept is very strong circumstantial evidence of copying of

that concept. 25

b. Petitioner’s Patent Applications Patent Owner asserts that Petitioner’s pursuit of their own “patent

protection on a radiation therapy system that mimics the ’765 patent,”

presumably Jaffray 2002, is evidence of copying. PO Resp. 61‒62 (citing

Ex. 2014, 31:10–32:22; Ex. 2080 ¶¶ 77, 215–220). As an initial matter, we

are unclear as to the relevance of Petitioner’s statements concerning non-

obviousness and praise of their own invention in the context of copying.

25 Petitioner does cite the cross-examination testimony of Dr. Hashemi as purportedly casting doubt on this assertion. Pet. Reply 23 (citing Ex. 1502, 159:10-19, 160:8-161:22). We note, however, that none of the testimony refers to the citation.

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Moreover, Petitioner replies that Patent Owner has not provided any

evidence as to how exactly Petitioner copied Jaffray 2002, other than

arguing that the content of Petitioner’s patent application meets the

limitations of independent claim 1, which itself is not sufficient to showing

copying. See Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir.

2010) (“[C]opying requires evidence of efforts to replicate a specific

product.”) Additionally, Petitioner provides further evidence that the work

on the content of Petitioner’s patent applications predated, and, thus, could

not have copied, Jaffray 2002. Pet. Reply 23–24 (citing Ex. 1500 ¶ 84;

Ex. 1512, 103–118; Ex. 1513; Ex. 1514). We agree with Petitioner on all

accounts.

c. Conclusion In summary, we find that Patent Owner has provided (1) very strong

circumstantial evidence of copying by Thilmann, and (2) no evidence of

copying by Petitioner. When weighed in the aggregate, we find that Patent

Owner has proffered moderately strong evidence of copying of, and, hence,

non-obviousness of, the invention set forth in independent claim 1. As

discussed above, independent claims 7, 20, and 26 recite substantially the

similar limitation, and, therefore, our analysis applies to these claims as well.

vi. Overall Weighing of Relevant Factors Concerning Obviousness, Including Secondary Considerations

We now weigh Patent Owner’s evidence of secondary consideration

in conjunction with the other factors relevant to obviousness for independent

claim 1. In summary, we find, for the reasons set forth above, that

Adler/Depp accounts for all of the limitations of independent claim 1, with

the exception of 3D cone-beam computed tomography. For that, we find

that it would have been within the abilities and knowledge of one of ordinary

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skill in the art, at the time of the claimed invention, to modify the

radiotherapy systems of Adler/Depp to include the 3D cone-beam computed

tomography system of Cho, Antonuk, and Jaffray 1997 in order to, among

several reasons, improve the quality and accuracy of Adler/Depp’s imaging

during radiotherapy. See Pet. 46–50; accord PO Resp. 21‒22 (“[T]he

ground raised in the Petition should be limited to the combination of the

radiotherapy systems of Adler/Depp as the primary reference modified to

include a CBCT-FPI system allegedly disclosed in the combination of Cho,

Antonuk, and Jaffray 1997.”) We find further that Petitioner has identified

sufficient evidence, in the cited prior art, that the modification itself, as well

as the rationale for the modification, were well known to one of ordinary

skill in the art, at the time of the invention.

Against the above findings, we weigh the Patent Owner’s evidence of

secondary considerations, each of which we have analyzed above, and

summarize as follows: (1) very strong evidence of industry praise; (2) very

strong evidence of long-felt need; (3) moderately strong evidence of

commercial success; and (4) moderately strong evidence of copying.

Overall, upon weighing the factors, we determine that the very strong

evidence of each of industry praise and long-felt need, as well as the

moderately strong evidence of each of commercial success and copying,

outweigh our finding that the radiotherapy systems of Adler/Depp, as

modified to include the 3D cone-beam computed tomography system of

Cho, Antonuk, and Jaffray 1997, account for every limitation of independent

claim 1. In particular, we find that the evidence of secondary considerations

is in agreement with the key advance in technology being the exact

modification of Adler/Depp, in view of Cho, Antonuk, and Jaffray 1997, as

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advanced by Petitioner. The Exhibits we find especially compelling are as

follows: 2012, 2015, 2071, and 2072. The Exhibits we find moderately

favorable to Patent Owner are as follows: 2034, 2035, 2054, and 2055. As

discussed above, independent claims 7, 20, and 26 recite substantially the

similar limitation and, therefore, our analysis applies to these claims as well.

Furthermore, as claims 2‒6, 8‒13, 21‒25, and 27‒31 each depend ultimately

from independent claims 1, 6, 20, and 26, we determine that a similar

weighing for each of claims 2‒6, 8‒13, 21‒25, and 27‒31 results in the same

conclusion.

Accordingly, for these reasons, we determine that Petitioner has not

met its burden of showing that claims 1–13 and 20‒31 are obvious in view

of the combination of Cho, Antonuk, Jaffray 1997, Adler, and Depp, for the

reasons discussed above.

9. Conclusion For the foregoing reasons, we are unpersuaded that Petitioner has

shown, by a preponderance of the evidence, that claims 1–13 and 20‒31 are

obvious in view of the combination of Cho, Antonuk, Jaffray 1997, Adler,

and Depp.

E. Patent Owner’s Motion to Exclude Patent Owner requests that “Exhibits 1114–1128, 1130, 1133, and

1135 (‘Exhibits’) and Paragraphs 115–143 of Exhibit 1102 (‘Balter

Testimony’) be excluded and expunged from the record” because they are

“irrelevant to the ground on which this proceeding was instituted” and “the

exhibits have not been cited by either Party.” PO Mot. 1. Petitioner

responds that Exhibits 1112–1138 were cited, albeit in a cursory manner, at

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pages 3‒4 of the Petition (Pet. Opp. 1), and that the Board has, effectively,

already excluded the referenced Exhibits and testimony as follows:

This interpretation is also consistent with the Board’s determination in its Institution Decision that the exhibits in question should not be relied upon to “‘fill in’ any ‘gap’ in the Petition.” (See Paper 14 at 23.) Thus, in this case Patent Owner already obtained adequate relief for its concerns regarding the supposedly “extraneous” Exhibits and Balter Testimony by virtue of the Institution Decision. As Patent Owner acknowledged in its motion, Petitioner complied with the Board’s directive did not rely on this evidence in its Reply papers. (See Paper 48 at 2.)

Pet. Opp. 2. Patent Owner replies that retaining the Exhibits and testimony

leaves open the possibility that Petitioner may attempt to rely on them

during appeal. PO Reply 2–3.

Patent Owner’s Motion is denied. Petitioner does refer to the

referenced Exhibits, however, briefly, in the Petition, and so retaining the

papers would assist the public, however minimally, in better understanding

the record. Furthermore, this Decision does not rely on portions of those

Exhibits or testimony, and we determine expressly that it is improper for

Petitioner to rely on those Exhibits and testimony, because, other than the

cursory mention, their relevance was not explained adequately with respect

to any ground of unpatentability in the Petition. Additionally, that Petitioner

may use such Exhibits and testimony on appeal is speculative. Finally, as

this Decision determined that the evidence of secondary considerations

outweighed the other factors of obviousness, and these Exhibits and

testimony would, at best, be of use only to potentially bolster Petitioner’s

positions on those other factors on which Petitioner already prevailed, we do

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not discern sufficient prejudice to Patent Owner to justify exclusion and

expungement.

F. Petitioner’s Allegedly Improper New Arguments and Evidence in Reply

We have considered Patent Owner’s listing (Paper 50) and

Petitioner’s responsive listing (Paper 58) on this issue. Patent Owner’s

assertions are moot, because our Decision does not rely on those portions of

the Reply and Dr. Balter’s Supplemental Declaration.

G. Papers Under Seal This Final Written Decision discusses or cites information in papers

that are subject to a Protective Order. For those papers, the Parties should

follow the guidance related to 37 C.F.R. § 42.56. See Office Patent Trial

Practice Guide, 77 Fed. Reg. 48,756, 48,761 (Aug. 14, 2012).

III. CONCLUSION

Petitioner has not demonstrated, by a preponderance of the evidence,

that claims 1–13 and 20‒31 of the ’765 patent are unpatentable. Patent

Owner’s Motion to Exclude is denied.

IV. ORDER

In consideration of the foregoing, it is hereby:

ORDERED that claims 1–13 and 20‒31 of the ’765 patent are not

held unpatentable;

FURTHER ORDERED that Patent Owner’s Motion to Exclude is

denied; and

FURTHER ORDERED that because this is a final written decision,

parties to the proceeding seeking judicial review of the decision must

comply with the notice and service requirements of 37 C.F.R. § 90.2.

Case IPR2016-00170 Patent 7,471,765 B2

72

PETITIONER:

Heidi L. Keefe Daniel J. Knauss Scott Cole Reuben Chen COOLEY LLP hkeefe@cooley.com dknauss@cooley.com scole@cooley.com Varian_PTAB_IPR@cooley.com

PATENT OWNER:

Theresa M. Gillis Amanda K. Streff MAYER BROWN LLP TGillis@mayerbrown.com AStreff@mayerbrown.com Gregory A. Morris Jonathan P. O’Brien HONIGMAN MILLER SCHWARTZ AND COHN LLP gmorris@honigman.com jobrien@honigman.com